Neoplasms

All Conditions

Rare Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Pancreatic Neuroendocrine Tumor

Neuroepithelioma

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Antineoplastic Agents

Ethanol

Ethiodized Oil

Anti-Infective Agents, Local

By using 3D-volumetric analysis, the optimal volume of ethanol is calculated by computer estimation of areas on each axial image, using EUS software permitting volume calculation. After calculating optimal ethanol volume by 3D volumetric analysis, we advance the needle into the tumor and inject estimated volume of ethanol/lipiodol (1:1 mixture), typically 1 to 1.5 ml.

By using 3D-volumetric analysis, the optimal volume of ethanol/lipiodol (1:1 mixture) is calculated by computer estimation of areas on each axial image, using EUS software permitting volume calculation. After calculating optimal ethanol volume by 3D volumetric analysis, we advance the needle into the tumor and inject estimated volume of ethanol, typically 1 to 1.5 ml.

EUS-guided ethanol-lipiodol mixture ablation

Do Hyun Park, MD, PhD

The present study evaluate the safety and efficacy of EUS-guided ethanol-lipiodol ablation for the treatment of pancreatic NET

Pancreatic neuroendocrine tumor, including insulinoma, increasingly are being encountered in clinical practice. Management of pancreatic NET is challenging because most are asymptomatic but may have malignant potential, and surgical resection of pancreatic neoplasm is associated with substantial morbidity of 20%-40% and a mortality rate of 2%. Management strategy needs to be individualized, applying a risk-benefit analysis to each patient. Recently, pancreatic tissue ablation by EUS-guided injection of ethanol or other chemotherapeutic agents can be performed safely, with few procedure-related complications. Levy et al. demonstrated that EUS-guided ethanol ablation for insulinoma was both safe and feasible, and symptomatic improvement was achieved in 8 of 8 patients (100%). However, previous study have included only a small number of patients and evaluated only short-term outcomes. In addition, lipiodol permits the drug to concentrate in the tumor. To obtain an embolic effect and prevent washout of the ethanol, ethanol/lipiodol mixture is administered into the tumor. The present study evaluate the safety and efficacy of EUS-guided ethanol-lipiodol ablation for the treatment of pancreatic NET

EUS-guided Ethanol-lipiodol Ablation of Pancreatic Neuroendocrine Tumor: a Prospective Study

EUS-guided Ethanol-lipiodol Ablation of Pancreatic Neuroendocrine Tumor: a Prospective Feasibility and Long Term Outcome

Technical success was defined as the ability to access and inject the mixture of ethanol/lipiodol into target tissue.

Final tumor viability will be assessed using contrast enhanced CT, and EUS-guided FNA at 3 years after procedure

Adverse events were defined as any procedure-related complications during the procedure or within 3 months, including pancreatitis, bleeding, and peripancreatic fluid collection

Dankook University

Asan Medical Center

Associate Professor

Gland and Hormone Related Diseases

Thyroid Diseases

Thyroid Nodule

Endocrine System Diseases

Thyroid Neoplasms

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Treatment with radiofrequency ablation for the thyroid lesions and compare the results with ethanol ablation in terms of volume reduction at 6-month follow-up (primary end point).

Treatment of predominantly cystic nodule with ethanol ablation and compare these results to radiofrequency ablation in terms of volume reduction at 6-month follow-up.

radiofrequency ablation for the treatment as a new therapy as compared with ethanol ablation as a conventional therapy

radiofrequency ablation

ethanol ablation as a conventional/control therapy to be compared with a new experimental therapy--radiofrequency ablation

Ethanol ablation

Jung Hwan Baek, MD

Ultrasound-guided ethanol ablation is an effective treatment modality for patients with cystic thyroid nodules (cystic portion \> 90%); however it is less effective in predominantly cystic thyroid nodules (90% \> cystic portions \> 50%). The volume reduction after EA has been reported 64% - 69.8% for predominantly cystic thyroid nodules. EA is insufficient for 26% (27/103) of patients with predominantly cystic thyroid nodules. Radiofrequency ablation to patients with incompletely resolved clinical problems after EA and the mean volume reduction ratio was 92% at 6-month follow-up. It is well known that RF ablation is effective in both predominantly cystic and solid thyroid nodules. Although RF ablation has effectively treated the patients who were unsatisfactory after EA, to the best of our knowledge, no study to date has compared these two ablation techniques. Therefore investigators performed a prospective randomized study to compare single-session RF ablation and EA for treating predominantly cystic thyroid nodules.

Ablation Procedures Both RF ablation and EA will perform with each patient in the supine position and with mild neck extension. Before the treatment, investigators will measure the three orthogonal diameters of each nodule, i.e, the largest diameter and two other, mutually perpendicular diameters, and the volume of each nodule was calculated using the equation V = π abc/6, where V is the volume, a is the largest diameter, and b and c are the other two diameters. Investigators will use 2% lidocaine at skin puncture site. The skin will be punctured, and target nodules will be approached using the trans-isthmic approach method in which the RF ablation electrode or EA needle is inserted into the short axis of the nodule from the isthmus to the targeting nodule. This technical approach has several advantages. It can prevent a change in the position of the needle or electrode when the patient is swallowing or talking during the ablation and can also prevent fluid leakage, i.e. injected ethanol or ablated, hot fluid of the cystic portion of thyroid nodules, to areas outside the thyroid gland. This approach also allows clear, continuous US monitoring of the relationship of the nodule, the needle or electrode tip, and the expected location of the recurrent laryngeal nerve, thus minimizing the risks of injury to that nerve and/or the esophagus.

Radiofrequency Ablation All patients will be required to fast for at least six hours before each procedure. Before starting the RF ablation, investigators will aspirate the internal fluid as much as possible .

Moving shot technique for thyroid RF ablation has been proposed. In treatment of the liver, the electrode is fixed during ablation. Because the thyroid is a relatively small organ compared with the liver, prolonged fixation of the electrode is dangerous. Investigators therefore divide thyroid nodules into multiple conceptual ablation units, and perform RF ablation unit by unit by moving the electrode tip. These conceptual ablation units are smaller in the periphery of the nodule and in the portion of the nodule adjacent to the critical structures of the neck; however the units are larger in the central safe portion. Initially, the electrode tip will be positioned in the deepest, most remote imaginary unit of the nodule to enable easy monitoring of the electrode tip without the disturbance caused by microbubbles. The electrode moves within the thyroid mass by tilting it upward or downward. When ablation in the peripheral unit was finished, the electrode will be moved backward and in the superficial direction. Ablation will begin with 40 W of RF power. If a transient hyperechoic zone do not form at the electrode tip within 5-10 seconds, RF power was increased in 10-W increments up to (100) W. If the patient do not tolerate pain during the ablation, the RF power will be reduced or turned off. Ablation will be terminated when all imaginary units had changed to transient hyperechoic zones.

Investigators will check for any possible complications both during and immediately after the procedure in order to assess its safety. Procedure-related pain will be graded into four categories, i.e. grade 0, RF power did not have to be turned off because a patient experienced no pain; grade 1, RF power was turned off 1-2 times because the patient's pain; grade 2, RF power was turned off more than three times because of the patient's pain; and grade 3, RF procedure was incompletely terminated due to the patient's severe pain. After RF ablation, each patient will be observed for 1-2 hours while still in the hospital.

Ethanol Ablation A 16- or 18-gauge needle will be inserted into the nodule through an isthmus. After the needle tip is placed into the cystic portion, the internal fluid will be aspirated to the maximal extent possible, followed by slow injection of 99% ethanol into the cystic space. If the cyst contents are viscous, Investigators will aspirate viscous fluid using a large-bore needle (16-gauge) attached to a 30-mL syringe, and followed by irrigation with normal saline to remove viscous material attached to the cystic wall or solid component, after which ethanol will be injected. The volume of ethanol injected usually corresponded to 50% of the aspirated volume. After 2 minutes of ethanol retention with the needle in place, the injected ethanol will be completely removed and the needle was withdrawn. Investigators will not inject the ethanol to solid component. In order to assess its safety, Investigators will check for any complications during and immediately after the procedure. Procedure-related pain will be graded into four categories, i.e. grade 0, no pain or mild pain similar to pain experienced during the lidocaine injection; grade 1, pain greater than that of the lidocaine injection, but not requiring medication; grade 2, pain requiring medication; and grade 3, the procedure was incompletely terminated due to severe pain (1). Following the procedure, each patient was observed for 30 minutes while still in the hospital.

RFA (Radiofrequency Ablation) Versus EA (Ethanol Ablation) for Predominantly Cystic Thyroid Nodules

Single Session Treatment of RFA Versus EA for Predominantly Cystic Thyroid Nodules: A Randomized Controlled Trial

Associate professor

Digestive System Diseases

Insulinoma

Adenoma

Adenoma, Islet Cell

Neoplasms, Glandular and Epithelial

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Pancreatic Cancer

Patients with Insulinomas will received EUS-guided ethanol ablation therapy

Diagnostic evaluation for suspected insulinoma is performed by cytology or immunohistochemistry. EUS-FNA is performed to obtain samples. After puncturing with the needle, ethanol under the guidance of EUS was injected into the lesion. The amount of ethanol is administrated according to the size of lesion.

EUS-guided ethanol ablation

Shanyu Qin, MD. Ph.D.

The present study aims to evaluate the feasibility, safety and efficacy of EUS-guided ethanol ablation of an insulinoma.

As the major insulinomas are functioning islet cell tumors, surgical resection is currently first-line therapy for or treatment of insulinomas. However, the surgical resection of pancreatic neoplasm is conditional for specific patients and may be associated with substantial life-threatening complications. Several studies declared that endoscopic ultrasound (EUS)-guided lavage may offer an alternative to surgical resection of insulinomas. Nevertheless, their sample sizes were small and conclusions were built based on short-term outcomes. In addition, the amount of ethanol administrated for different types of insulinomas were inconsistent among those studies.

The present study aims to evaluate the safety, feasibility and efficacy of EUS-guided ethanol ablation therapy of insulinomas. We will use cytopathology and immunohistochemistry in combination with EUS-FNA for diagnosis of insulinoma. After EUS-guided ethanol ablation therapy, the safety and efficacy will be assessed at the baseline and different time points during follow-up by physicians blinded to the treatment or control status.

EUS-guided Ethanol Ablation of an Insulinoma

Endoscopic Ultrasound (EUS)-Guided Ethanol Ablation of an Insulinoma - A Multi-center Prospective Cohort Study

Volumes of insulinomas before and after treatment, which are measured by cross-sectional imaging test (CT or MRS).

Number of subjects with post-procedure adverse events

Technical success was defined as ethanol is injected and lavaged into target tissue.

Guangxi Medical University

First Affiliated Hospital of Guangxi Medical University

Symptoms and General Pathology

Cysts

Cystadenoma

Neoplasms, Cystic, Mucinous, and Serous

Pancreatic Adenoma

Ethanol injection into a cyst

William R. Brugge, MD

The purpose of the study is to learn about a new treatment for pancreatic cystic lesions. The injection of alcohol into cysts is a common way of treating cysts of the liver, kidney, and thyroid. We would like to find out if injection of alcohol would be useful for the treatment of pancreatic cystic lesions. The treatment with alcohol will use endoscopy and endoscopic ultrasound (procedures that use a scope that is placed through your mouth and into your stomach). We hypothesize that more than half of the cysts which are injected with ethanol will resolve.

Cystic lesions of the kidney, thyroid, and liver are commonly treated with ethanol injections into the cyst cavity. The contact with ethanol results in rapid elimination of epithelial cells lining cyst cavities with few complications or pain. The majority of cysts become smaller and some are completely eliminated Depending on the type of cyst and tissue, some cysts can be completely ablated with ethanol. Although malignant masses arising from the pancreas have been safely injected with ethanol, there are no reports of injection of pancreatic cystadenomas. The ability to ablate cystadenomas of the pancreas would provide the first non-surgical treatment for these pre-malignant lesions of the pancreas.

Over the past two years we have conducted a pilot study of EUS-guided ethanol lavage of pancreatic cysts (2001-P-000358/5). 18 patients have undergone the procedure without evidence of pancreatitis, pain, or infection following the procedure. Initially, low concentrations of ethanol were used (5%) and over the course of the study, the concentration of the ethanol used for lavage has been increased to 60%. Although the patients have not undergone careful follow-up evaluations, it appears that at least 4 of the patients have had resolution of the cyst.

This is a prospective, randomized, blinded, controlled trial of ethanol ablation in 50 patients with a pancreatic cystadenoma. Patients with a pancreatic cyst (1-5cm in diameter) capable of safely undergoing endoscopy with conscious sedation will be candidates. Exclusion criteria include: coagulopathy (INR\>1.5, PTT\>100, platelets of\< 50k), active infection of the cyst or unstable cardio-pulmonary disease (active angina, home O2, or pulmonary edema) will be excluded.

At the time of diagnostic cyst aspiration, the patient will be randomized to either saline lavage or ethanol (70%) lavage. During the exam, the cyst will be imaged with ultrasound, measured and aspirated. The cyst contents will be evaluated with cytologic evaluation, CEA, and amylase. After cyst aspiration, the cyst will be lavaged with either saline or ethanol for 5 minutes. At completion of the lavage, the cyst contents will be evacuated. The patient will be provided the results of the cyst fluid analysis and may elect to undergo surgical resection or additional lavage treatments. At the time of resection, the cyst and surrounding pancreas will be resected for histologic analysis. The degree of epithelial ablation will be determined with histologic sectioning and the cysts lavaged with ethanol will be compared to those cysts lavaged with saline. If the patient chooses not to have a surgical resection, the patient may return for a follow-up EUS exam at two additional monthly intervals with cyst aspiration and additional ethanol lavage. Those patients receiving saline during the initial treatment session will be crossed-over to ethanol.

EUS-Guided Pancreatic Injection of Cyst (EPIC) Trial

Indiana University School of Medicine

Massachusetts General Hospital

Director of Pancreas and Biliary Center

Anti-Arrhythmia Agents

Channel Blockers

Pharmaceutical Solutions

Anesthetics

Lidocaine

Anesthetics, Local

Sodium Channel Blockers

Diuretics, Potassium Sparing

EUS-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.

EUS-guided lavage of a pancreatic cystic neoplasm with ethanol solution. Ethanol was diluted to 80% using normal saline.

The final solution contained 1% lidocaine except in subjects allergic to local anesthetics.

Mark Topazian, MD

Cystic tumors of the pancreas are fluid-filled growths. They are often treated by surgical removal. A safe and effective non-surgical treatment is desirable. Ethanol (alcohol) injection may treat cysts by killing the lining cells of the cyst, and is an accepted treatment for cysts of other organs. In this study, participants with pancreatic cysts underwent endoscopic ultrasound (EUS) guided ethanol injection of pancreatic cysts. This was a pilot study to assess safety and efficacy.

The hypotheses of this study were 1) complications of EUS guided ethanol injection requiring hospitalization will occur in \<10% of subjects, and 2) EUS guided ethanol injection, with retreatment as necessary, will ablate at least 50% of pancreatic cysts.

EUS is performed via the mouth under sedation. After a needle is placed into the pancreas cyst under EUS guidance, an ethanol solution is placed into the cyst via the needle. The ethanol solution is withdrawn and new ethanol injected, and this process is continued for 5 minutes, repeatedly washing the cyst with the ethanol solution.

After this treatment, usual clinical follow-up is obtained including assessments of the cyst by CT or MRI scans. If a cyst of significant size persists, additional EUS-guided ethanol injections of the cyst were offered.

Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms

Data sharing can be arranged and will require IRB approval

Adverse events include pancreatitis, bleeding, perforation, any other occurrence resulting in hospitalization, medical treatment, surgery, death, or disability

Complete or partial ablation of cysts will be defined by the presence of a persistent cystic structure, and its volume and maximum diameter, as determined by cross-sectional imaging studies (CT, MR)

Mayo Clinic

Professor of Medicine

Pancreatic Cyst Ethanol Injection

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Only subjects who received the study intervention, endoscopic ultra sound (EUS)- guided ethanol lavage were included in the baseline analysis.

Sample size was small, and a control group was not included. Neither cyst histology not degree of epithelial ablation was assessed by surgical resection in any of the study participants.

Dr. Mark Topazian

Number of participants with adverse events

Number of participants without adverse events

Number of Participants With Adverse Events as a Measure of Safety and Tolerability

Complete ablation of treated cyst

Greater than or equal to 80% cyst volume reduction

Less than 80% cyst volume reduction

Cyst volume increase

Number of Subjects With Complete or Partial Ablation of the Treated Cyst

Endoscopic ultrasound (EUS)-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.

Overall Study

Pancreatic Cyst

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Cyst will be lavaged for 3-5 minutes with Ethanol (alcohol 80%). Following lavage with Ethanol (alcohol 80%), The cyst will be infused with an admixture of chemotherapy drugs (Paclitaxel/ Gemcitabine) 3mg/ml paclitaxel and 19mg/ml gemcitabine.

Cyst will be lavaged for 3-5 minutes with Normal Saline .. Following lavage with Normal Saline, The cyst will be infused with an admixture of chemotherapy drugs (Paclitaxel/ Gemcitabine) 3mg/ml paclitaxel and 19mg/ml gemcitabine.

Cysts will be lavaged for 3-5 minutes with 80% EtOH

Cysts will be lavaged for 3-5 minutes with normal saline

Normal Saline

Following lavage with either 80% ethanol (control group) or normal saline (study group), cysts will be injected with a cocktail of 3mg/ml paclitaxel and 19mg/ml gemcitabine.

Chemotherapy

The purpose of this study is to evaluate the efficacy of a chemotherapeutic cocktail with or without prior ethanol lavage for ablation of premalignant pancreatic cysts using endoscopic ultrasound-guided fine needle injection (EUS-FNI) for agent delivery.

While about half of pancreatic cystic lesions have little to no malignant potential, mucinous cystic neoplasms (MCNs) and intraductal papillary mucinous neoplasms (IPMNs) carry a high potential for progression into pancreatic cancer. Therefore, either close radiographic surveillance or surgical resection is generally recommended for these cysts. However, pancreatic surgery is associated with a significant risk of morbidity and mortality and not all patients are good surgical candidates. As an alternative, endoscopic ultrasound-guided fine needle injection(EUS-FNI) has been shown to be moderately effective in ablating cystic lesions.

The goal of this investigation is to improve the efficacy and safety of this procedure when compared with previous versions of the technique. This study is designed to evaluate the efficacy of a chemotherapeutic cocktail with or without prior ethanol lavage for ablation of pancreatic cystic neoplasms using EUS-FNI for agent delivery. This paired, prospective, double-blind, randomized study will include 78 patients referred to the Penn State Hershey Medical Center. Mucinous or indeterminate pancreatic cysts of 1-5cm with less than 5 compartments and without clear communication with the main pancreatic duct will be included. Patients will be randomized in a 1:1 ratio into a control arm or study arm. Patients randomized to the control arm will receive ethanol lavage of the cyst followed by injection of two carefully selected chemotherapeutic agents. Study arm patients will receive a normal saline lavage followed by injection of the same chemotherapy admixture. Patients will be monitored for 2 hours post-procedure, and a follow-up CT will be performed at 6, and 12 months, or as determined necessary to evaluate cyst resolution. Patients may elect to undergo evaluation for surgical resection at any time, regardless of response, in which case a dedicated pathologist will evaluate any surgical specimens.

The CHARM Trial: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts

The primary outcome of interest will be change in cyst size, as measured on initial, 6, and 12 month CT/MRI, or as determined necessary to evaluate cyst resolution. Cyst size was calculated by measuring x and y diameters and calculating cyst volume using the formula:4/3xpxr3 where r is the average of the cyst radius as measured on the initial, 6-month, and 12-month magnetic resonance imaging or computed tomography. Response was defined according to the same volume percentage reductions as described in previous trials where: complete response is a =\>95% reduction in cyst volume, partial response is a 94%-75% reduction, and anon-response is \<75% reduction in volume.11 The overall ablation rates in both arms were also compared with historical controls to assess the efficacy of the chemotherapeutic cocktail.

Milton S. Hershey Medical Center

Assistant Professor

Cyst will be lavaged for 3-5 minutes with Ethanol (alcohol 80%). Following lavage with Ethanol (alcohol 80%), The cyst will be infused with an admixture of(Paclitaxel/ Gemcitabine) 3mg/ml paclitaxel and 19mg/ml gemcitabine.

Ethanol: Cysts will be lavaged for 3-5 minutes with 80% EtOH

Chemotherapy: Following lavage with either 80% ethanol (control group) or normal saline (study group), cysts will be injected with a cocktail of 3mg/ml paclitaxel and 19mg/ml gemcitabine.

Control Group

Cyst will be lavaged for 3-5 minutes with Normal Saline .. Following lavage with Normal Saline, The cyst will be infused with an admixture of(Paclitaxel/ Gemcitabine) 3mg/ml paclitaxel and 19mg/ml gemcitabine.

Normal Saline: Cysts will be lavaged for 3-5 minutes with normal saline

Chemotherapy: Following lavage with either 80% ethanol (control group) or normal saline (study group), cysts will be injected with a cocktail of 3mg/ml paclitaxel and 19mg/ml gemcitabine.

Study Group

Ethanol: Cysts will be lavaged for 3-5 minutes with 80% EtOH

Chemotherapy: Following lavage with either 80% ethanol (control group) or normal saline (study group), cysts will be injected with a cocktail of 3mg/ml paclitaxel and 19mg/ml gemcitabine.

Normal Saline: Cysts will be lavaged for 3-5 minutes with normal saline

Chemotherapy: Following lavage with either 80% ethanol (control group) or normal saline (study group), cysts will be injected with a cocktail of 3mg/ml paclitaxel and 19mg/ml gemcitabine.

Total

Age, Categorical

Race (NIH/OMB)

Because of small number of participants this single-center trial is still weakly powered to show these differences with high levels of scientific certainty.Study was limited to one ablation only.

Dr. Matthew T. Moyer

Complete Response after 6 mon

Partial Response after 6 months

No Response after 6 months

Complete Response after 12 months

Partial Response after 12 months

No Response after 12 months

Intent to treat population (all participants at least one dose of intervention)

Number of Participants With the Changing in Cyst Volume

Pathological Conditions, Anatomical

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Cyst will be lavaged for 3 to 5 minutes with \>/=99% ethanol. Following lavage with \>/=99% ethanol, the cyst will be infused with an admixture of (3mg/ml paclitaxel + 19mg/ml gemcitabine).

Cyst will be lavaged for 3 to 5 minutes with normal saline. Following lavage with normal saline, the cyst will be infused with an admixture of (3mg/ml paclitaxel + 19mg/ml gemcitabine).

The cyst will be lavaged for 3 to 5 minutes using \>/=99% ethanol as the lavage agent prior to infusing the cyst with the paclitaxel + gemcitabine admixture.

The cyst will be lavaged for 3 to 5 minutes using normal saline as the lavage agent prior to infusing the cyst with the paclitaxel + gemcitabine admixture.

Normal saline

Following lavage, cysts will be infused with an admixture of 3mg/ml paclitaxel and 19mg/ml gemcitabine.

Paclitaxel + Gemcitabine admixture

Matthew T. Moyer, MD, MS

The purpose of this study is to evaluate the efficacy and safety of chemotherapeutic pancreatic cyst ablation using ethanol lavage followed by the infusion of a dual-agent chemotherapeutic cocktail (paclitaxel + gemcitabine) compared with alcohol-free saline lavage followed by infusion of the same dual-agent chemotherapeutic cocktail (paclitaxel + gemcitabine) for the ablation of pancreatic cystic neoplasms using endoscopic ultrasound guided fine needle infusion (EUS-FNI) for agent delivery.

Pancreatic cystic lesions are increasingly encountered and typically discovered incidentally on cross-sectional imaging, occurring in approximately 2% of all American adults with a 37% prevalence in individuals over 80. Most of these cysts are mucinous (neoplastic) in origin and represent precursor lesions for pancreatic adenocarcinoma.

Discovering a pancreatic cyst typically presents a treatment dilemma, with options including either indefinite radiographic surveillance with MR (magnetic resonance) or CT imaging or surgical resection, both of which have significant limitations. Surveillance carries significant economic and possible psychological burdens while waiting for signs of malignancy to develop, as well as radiation exposure with computed tomography. On the other hand, surgical resection possesses a significant risk of serious adverse events (20%-40%) and mortality (1-2%). This clinical dilemma delineates the pressing need to develop effective, but more minimally invasive approaches for the elimination of these premalignant pancreatic cysts, and among these, endoscopic ultrasound guided fine needle infusion (EUS-FNI) has emerged as an innovative and promising approach. Between November 2011 and December 30, 2015, investigators from interventional endoscopy, surgical oncology, hematology oncology, and pathology of the Penn State Hershey Medical Center conducted the CHARM I clinical trial. This was a prospective, randomized, double-blind, single-center study with an N of 46 patients required for 80% power to prove non-inferiority. Final results from CHARM I were as follows: Patients treated included 23 females and 16 males with the majority of lesions located in the body and head of the pancreas. Both the alcohol and alcohol-free groups recorded a 47% rate of complete ablation at 6 months, which increased to 64% for both groups at the 1 year follow-up. One subject experienced a complication in the alcohol arm (6%), and no subjects experienced complications in the alcohol-free arm.

The overall objectives of CHARM II are to verify the significant findings of CHARM I in a multi-center clinical trial as requested by national investigators in this field. We expect that administering a specifically designed chemotherapeutic cocktail without prior ethanol lavage will result in an equivalent rate of cyst resolution with fewer complications when compared with lavage using alcohol. The results of this study will provide important information about the most efficient and safest method for treating premalignant pancreatic cysts, an important step for treating these lesions with a minimally invasive technique and preventing their progression to pancreatic cancer. Standard alternative treatment options for this patient group (if not taking part in this study) would be ongoing periodic radiographic surveillance with MR or CT imaging waiting for signs of malignancy to develop or to consider surgical resection (an option with significant rates of morbidity and mortality).

This is an investigator-initiated, prospective, randomized, double-blinded, multi-center study evaluating ethanol lavage and chemotherapy for the ablation of mucinous and indeterminate type pancreatic cysts with malignant potential. Participants will be screened for the study according to inclusion and exclusion criteria. After confirming their eligibility, patients will be randomized to one of the following EUS-FNI treatment arms in a 1:1 ratio:

Control arm: After removal of cyst fluid, cysts will be lavaged for 3 to 5 minutes with \>/=99% ethanol and then infused with an admixture of 3 mg/ml paclitaxel and 19 mg/ml gemcitabine.

Experimental arm: After removal of cyst fluid, cysts will be lavaged for 3 to 5 minutes with normal saline and then infused with an admixture of 3 mg/ml paclitaxel and 19 mg/ml gemcitabine.

Patients will be contacted by the study team via phone call at both 72 hours and 30 days after their EUS procedure to assess any adverse events that may have occurred. Within 2-3 weeks of the having the EUS procedure, patients will receive the cyst fluid pathology results. At 3 months after the initial procedure, patients will undergo a follow-up EUS examination in the same manner as the initial EUS exam. During this exam, a complete pancreaticobiliary evaluation will be conducted, and the diameter of the previously treated cyst will be measured in the x and y dimensions to assess the 3 month response. Any cyst still \>15mm and amenable to repeat ablation will undergo a second EUS-guided chemoablation treatment using the same lavage that the patient was randomized to initially. At both 12 months and 24 months after the initial procedure, the patient will be seen in the GI clinic and undergo either an MRI-MRCP (magnetic resonance cholangiopancreatography) or enhanced CT scan for a full pancreaticobiliary evaluation to assess the end-point treatment response.

CHARM II: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts

CHARM II: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts: a Prospective, Randomized, Double-blind, Multi-center Clinical Trial

This is defined as Complete response greater than or equal to 95% reduction in cyst volume and measured by "r" as cyst volume 4/3×π×r3 at 12 months post initial treatment

Based on definition of serious and minor adverse events, the two arms will be compared with respect to adverse events that took place within 30 days after the subject's procedure

National Cancer Institute (NCI)

Carcinoma

Carcinoma, Hepatocellular

Adenocarcinoma

Liver Neoplasms

Liver Diseases

Coagulants

Chlorotrianisene

Gelatin Sponge, Absorbable

Occlude APS with EGM and perform TACE sequentially

Occlude APS with PVA and perform TACE sequentially

TACE

Occlude arterioportal shunts(APS) with ethanol/gelfoam mixture(EGM)

Occlude arterioportal shunts(APS) with PVA

Haibin Shi, MD, PhD.

Gaojun Teng, MD., PhD.

Transcatheter arterial chemoembolization (TACE) is a key palliative treatment for patients with inoperable hepatocellular carcinoma (HCC). Arterioportal shunts (APS) can aggravate portal hypertension and the shunts let lipiodol flow to normal liver tissue and result in poor Lipiodol deposition in the tumor, causing liver ischemia.

Occlusion of APS is a vital and initial step for the following embolization of tumor. Ethanol-gelfoam mixture(EGM) and gelfoam only both can occlude APS in patients with hepatocellular carcinoma (HCC).

The aim of this study was to evaluate the efficacy and safety of EGM in treatment of APS in the procedure of TACE, and to analyze the prognostic factors for survival in this kind of patients.

Therapeutic Effect of Ethanol-gelfoam Mixture for the Treatment of Arterioportal Shunts (APS) in Patients With HCC

A Randomized Controlled Trial of Ethanol-gelfoam Mixture(EGM) Versus Gelfoam for the Treatment of Arterioportal Shunts (APS) in Patients With Hepatocellular Carcinoma (HCC) Treated With Transarterial Chemoembolization (TACE)

Defined as time (in days) from time of TACE non-eligibility to death due to any cause, and will be evaluated every 8 weeks in the protocol treatment, and every one year in the follow-up period, respectively. Patients lost to follow-up or alive at the end of the study will be censored at the last date known to be alive.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
EUS-guided Ethanol-lipiodol Ablation of Pancreatic Neuroendocrine Tumor: a Prospective Study	NCT01902238	Efficacy Safety Feasibility	EUS-guided etha...	18 Years -	Asan Medical Center
RFA (Radiofrequency Ablation) Versus EA (Ethanol Ablation) for Predominantly Cystic Thyroid Nodules	NCT01778400	Thyroid Nodule	radiofrequency ... Ethanol ablatio...	20 Years -	Asan Medical Center
EUS-guided Ethanol Ablation of an Insulinoma	NCT02121366	Insulinoma	EUS-guided etha...	18 Years - 80 Years	Guangxi Medical University
EUS-Guided Pancreatic Injection of Cyst (EPIC) Trial	NCT00233038	Pancreatic Cyst...	Ethanol injecti...	18 Years -	Massachusetts General Hospital
Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms	NCT02158039	Neoplasms, Cyst...	Ethanol Lidocaine	18 Years -	Mayo Clinic
The CHARM Trial: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts	NCT01475331	Mucinous Pancre...	Ethanol Normal Saline Chemotherapy	18 Years -	Milton S. Hershey Medical Center
Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms	NCT02158039	Neoplasms, Cyst...	Ethanol Lidocaine	18 Years -	Mayo Clinic
CHARM II: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts	NCT03085004	Pancreatic Cyst EUS-FNA	Ethanol Normal saline Paclitaxel + Ge...	18 Years -	Milton S. Hershey Medical Center
Therapeutic Effect of Ethanol-gelfoam Mixture for the Treatment of Arterioportal Shunts (APS) in Patients With HCC	NCT02338297	Carcinoma, Hepa...	TACE EGM PVA	18 Years -	Nanjing Medical University
Ethanol-Lock Treatment in Preventing Central Venous Catheter Infections in Patients With High-Risk Neuroblastoma	NCT00471679	Neuroblastoma	ethanol	-	Memorial Sloan Kettering Cancer Center
EUS-Guided Pancreatic Injection of Cyst (EPIC) Trial	NCT00233038	Pancreatic Cyst...	Ethanol injecti...	18 Years -	Massachusetts General Hospital
EUS-Guided Pancreatic Injection of Cyst (EPIC) Trial	NCT00233038	Pancreatic Cyst...	Ethanol injecti...	18 Years -	Massachusetts General Hospital
CHARM II: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts	NCT03085004	Pancreatic Cyst EUS-FNA	Ethanol Normal saline Paclitaxel + Ge...	18 Years -	Milton S. Hershey Medical Center
EUS-guided Ethanol-lipiodol Ablation of Pancreatic Neuroendocrine Tumor: a Prospective Study	NCT01902238	Efficacy Safety Feasibility	EUS-guided etha...	18 Years -	Asan Medical Center

Spots Global Cancer Trial Database for ethanol

Every month we try and update this database with for ethanol cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ethanol

Every month we try and update this database with for ethanol cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ethanol cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.