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Study natural history of VHL pancreatic neuroendocrine tumors with yearly 68-Gallium DOTATATE PET/CT research scans.

Study natural history of VHL pancreatic neuroendocrine tumors without research scans.

68-Gallium DOTATATE, to be used in yearly PET/CT research scans

68-Gallium DOTATATE

Kristine J Villaruel

Naris Nilubol, M.D.

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

Background:

People with von Hippel-Lindau (VHL) can have problems with a variety of organs, such as the pancreas. The disease can cause tumors of the pancreas. This can result in life-threatening complications. Researchers want to learn more about these pancreatic tumors and how to better detect them. This may help them design better future treatment and care for people with VHL disease.

Objective:

To better understand VHL disease that affects the pancreas and to test whether adding a certain type of scan (68-Gallium DOTATATE PET/CT) can further detect tumors.

Eligibility:

People ages 12 and older with VHL that causes tumors and cysts to grow in the pancreas

Design:

Participants will be screened with their medical records and imaging studies.

Participants will have an initial evaluation:

Participants will have their body examined by different doctors. This will depend on what types of symptoms they have.

Participants will have blood and urine tests

Participants will have images made of their body using one or more machines: They made have a CT or PET/CT scan in which they lie on a table that moves through a big ring. They may have an MRI in which they lie on a table that moves into a big tube. They may have an ultrasound that uses a small stick that produces sound waves to look at the body.

After the first visit, participants will be asked to return to the NIH. Some of the tests performed at the first visit will be repeated. Depending on their disease status, visits will be once a year or every 2 years for life.

Background:

* Patients with the von Hippel-Lindau (VHL) familial cancer syndrome demonstrate manifestations in a variety of organs, including the pancreas. Pancreatic manifestations can range from benign cysts and micro cystic adenomas to neuroendocrine tumors of the pancreas which are capable of regional and distant metastases. These neuroendocrine tumors can result in life-threatening complications.
* This protocol is designed to identify VHL patients with pancreatic manifestations and to follow these patients with serial imaging studies, germ line genetic analysis, discovery of serum biomarkers, and novel imaging modalities such as 68-Gallium DOTATATE PET/CT scan.

Objective:

- To comprehensively and longitudinally evaluate the natural history of patients with VHL pancreatic neuroendocrine tumors and cystic lesions, estimating and defining their clinical spectrum.

Eligibility:

- Patients greater than or equal to 12 years of age diagnosed with VHL.

Design:

* Demographic data will be collected from the medical record and patient interview for each patient participant. Data will be securely stored in a computerized database.
* Patients will be evaluated by the urology, neurosurgery, brain oncology and/or ophthalmology personnel as indicated to rule out or manage other manifestations of VHL such as hemangioblastoma, renal cell cancer, and pheochromocytoma.
* Anatomical and functional clinical imaging studies, research blood and urine sample collection will be performed at each scheduled visit. Research 68-Gallium DOTATATE PET/CT imaging studies in adult subjects will be performed, no more than once per year.
* Surgical resection of solid lesions of the pancreas will be recommended based on previously published criteria.
* Based on our analysis of likelihood of tumor growth or risk of metastasis, data will be analyzed every two years and appropriate revisions will be made to the surgical management guidelines, if indicated by data analysis.
* Projected accrual will be 40 patients per year for a total of 15 years. Considering some patients may have a screen failure, we anticipate accruing of 740 patients on this protocol.

Natural History and Management of Von Hippel-Lindau (VHL) Associated Pancreatic Neuroendocrine Tumors

Evaluation of the Natural History and Management of Von Hippel-Lindau (VHL) Associated Pancreatic Neuroendocrine Tumors

.All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.

Characterization of the natural and clinical histories of VHL pancreatic neuroendocrine tumors and cystic lesions

mean uptake between these two groups of adult patients in which per patient uptake is defined as the average uptake of multiple lesions detected in each patient

median amount of time from initial presentation with pancreatic tumors to the time that surgery is recommended

National Cancer Institute (NCI)

Hemorrhage

Blood Loss, Surgical

Intraoperative Complications

In the pancreatic enucleation, Kocher Maneuver was routinely performed at first. Then free the left side of the abdominal trunk and superior mesenteric artery, loose tissues easy to free.After Kocher Maneuver and other surgical procedures, the abdominal trunk and superior mesenteric artery exposed. Before resection of pancreatic tumors, a vascular occlusion clamp clip was used to block the root of both the abdominal trunk and superior mesenteric artery to control the pancreatic blood flow.

blocking both the abdominal trunk and superior mesenteric artery in the pancreatic enucleation

Sheng Yan, professor

Bo Zhou, Dr.

Pancreatic enucleation could preserve more healthy pancreatic tissues and functions with a low recurrence risk. However, conventional enucleation can cause significant intraoperative bleeding, especially in which tumors in the pancreatic head, neck, and uncinate process of pancreas, as these tissues are rich in blood supply, mainly including the abdominal trunk and the superior mesenteric artery. In this study, we developed a novel method to control the pancreatic blood flow in laparoscopic enucleation--blocking the abdominal trunk and superior mesenteric artery with vascular occlusion clips in the process of resection, and evaluated its effectiveness and safety.

Between March 2023 and May 2026, patients who underwent laparoscopic pancreatic enucleation by blocking both the abdominal trunk and superior mesenteric artery in the Second Affiliated Hospital of Zhejiang University would be included in our prospective study. Inclusion criteria: 1) benign or borderline tumors diagnosed pathologically, such as pancreatic neuroendocrine tumors, solid pseudopapillary tumors, and cystadenomas, without vascular invasion or distant metastasis;.2) tumors sited in the pancreatic head, neck, and uncinate process of pancreas; 3) blockade of both the abdominal trunk and superior mesenteric artery in the laparoscopic enucleation. Exclusion criteria:1) highly malignant pancreatic tumors, or tumors with infiltration or metastasis; 2) tumors of the body and tail of the pancreas;3) transfer to LPD or laparotomy. Patient characteristic including clinical, biochemical and radiological data will be recorded and analyzed. All patients will provide written informed consent before inclusion.

Enucleation of Pancreatic Tumor by Blocking Abdominal Trunk and Superior Mesenteric Artery

A Prospective Study of Enucleation of Pancreatic Tumor by Blocking Abdominal Trunk and Superior Mesenteric Artery

The IPD in the current study are available from central contact person upon reasonable request.

blockade of both the abdominal trunk and superior mesenteric artery changes the blood loss

Zhejiang University

Director, Head of Hepatology and Pancreatology, Principal Investigator, Clinical Professor.

Cysts

Pancreatic Cyst

Specimen collection via EUS Guided Fine Needle Aspiration EchoBrush Sampling

EUS-guided fine needle aspiration of the cyst fluid

EUS Guided Fine Needle Aspiration

EUS Guided EchoBrush Sampling

Shivakumar Vignesh, M.D.

The goal of this study is to compare a sample of the cyst taken by a standard method (fine needle aspiration) to the sample taken by a new method using a device called the EchoBrush to see which method is more accurate at diagnosing cancer. We will also look at proteins (also called biomarkers) in the samples to see if they predict whether or not the cyst is cancerous.

Patients who meet the inclusion and exclusion criteria will be offered the study and those who consent will undergo Endoscopic Ultrasound (EUS) evaluation. All patients who consent to the study will undergo Endoscopic Ultrasound guided fine needle aspiration (EUS-FNA) and EUS guided EchoBrush. All patients will receive the recommended standard antibiotic prophylaxis (Ciprofloxacin 400 mg IV given 30 minutes prior to EUS) that is used prior to EUS-FNA of cystic pancreatic lesions and a prescription for oral Ciprofloxacin for 5 days post procedure (standard of care).

Participants with pancreatic cysts that are \>10 mm but under 25 mm: These patients will undergo standard EUS-FNA of cyst fluid. From the first 19 participants, 0.5cc of aspirated cyst fluid will be sent for Proteomic analysis and the rest for cytology. EUS guided EchoBrush of the cyst wall will not be performed in this group of patients.

Participants with pancreatic cysts that are \> 25 mm will undergo EUS guided Echobrush sampling of the cyst wall at the same time they undergo EUS-FNA. This will be done using the standard technique that is described below.

EUS guided cyst wall brushing and residual fluid aspirated after lavage with 2 cc of sterile normal saline The tip of the Echobrush and the saline used to lavage the cyst will be placed in the same specimen jar (Specimen 2) based on the discussion with published experts on the EchoBrush technique. It should be noted that the pancreatic cyst will be punctured with the 19G FNA needle only once to obtain the specimens mentioned above. A single pass with EUS-FNA is the standard of care for pancreatic cysts and this study does not alter standard of care. It should be noted that the two groups represent two samples from the same patient and same cystic lesion. Therefore each patient will serve as their own internal control. All patients will be considered for surgical resection. Patients who do not undergo surgical resection will be followed up per standard of care.

Cataloguing the proteins that are expressed in pancreatic cyst fluid will provide preliminary data that will be used for identification of candidate biomarkers to predict malignant transformation.

Evaluation of Image-guided Brushing of Pancreatic Cyst Wall in Diagnosis of Cystic Pancreatic Tumors

Evaluation of Image-guided Brushing of Pancreatic Cyst Wall in the Diagnosis of Cystic Pancreatic Tumors

The difference in diagnostic accuracy between the cytological grade of dysplasia on aspirated cyst fluid cytology (Specimen/ Group 1) and Echo Brush cytology (Specimen/ Group 2) when compared to surgical histology (Specimen 3).

Specifically, the cellularity (scored 0 to 3) of specimen 1 will be compared to specimen 2 using the two-sample proportion test. In addition, the Spearman's rank correlation will be used to calculate the correlation between cytological grade of dysplasia of specimen 1 to specimen 3, and the correlation between specimen 2 to specimen 3.

Cataloging proteins that are expressed in the cyst fluid collected from Pancreatic cystic tumors using Proteomic analysis.

American Cancer Society, Inc.

H. Lee Moffitt Cancer Center and Research Institute

Fistula

Pancreatic Fistula

Pathological Conditions, Anatomical

Digestive System Fistula

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

Pancreaticogastrostomy (PG) reconstruction/anastomosis after pancreaticoduodenectomy (PD)

Pancreaticojejunostomy (PJ) reconstruction/anastomosis after pancreaticoduodenectomy (PD)

Pancreaticojejunostomy (PJ) reconstruction/anastomosis

Pancreaticojejunostomy

Pancreaticogastrostomy (PG) reconstruction/anastomosis

Pancreaticogastrostomy

Baki Topal, MD, PhD

Claude Bertrand, MD

Jean Closset, MD, PhD

Henk Thieren, MD

Franky Vansteenkiste, MD

Jean-Francois Gigot, MD, PhD

Joseph Weerts, MD

Geert Roeyen, MD

Marc Janssens, MD

Tom Feryn, MD

Steven Pauli, MD

The incidence of complications after pancreaticoduodenectomy (PD) is around 50 %. The postoperative course after PD is strongly dependent of the occurrence of pancreatic fistula (POPF), which determines postoperative mortality, length of hospital stay and costs. The incidence of POPF after PD is dependent of its definition, and is reported in up to 20% of patients.

There is disagreement on whether to perform a pancreaticojejunostomy (PJ) or a pancreaticogastrostomy (PG) after PD. The aim of the current randomized controlled trial is to study whether PG significantly reduces the rate of POPF following PD for pancreatic or peri-ampullary tumours. Secondary endpoints are the reduction of overall postoperative complication rate and their severity.

Therapeutic intervention

* Surgeons who have performed a minimum of five (5) PG and PJ procedures can include patients in this randomized trial.
* Any dissection device or technique is allowed.
* Pancreatic anastomosis (PG or PJ)

  * 1-layer or 2-layer anastomosis is allowed but has to be registered
  * mono-filament and/or poly-filament suture material is allowed but has to be registered
  * no pancreatic stent will be placed
* Drainage: one (1) or more closed drain(s) with or without suction is allowed in the vicinity of the pancreatic anastomosis
* Enteral tube feeding (tube positioned in the jejunum at the time of surgery, and distal to the pancreatic anastomosis) as well as total parenteral nutrition (TPN) is allowed
* Gastrostomy tube (percutaneous) is allowed
* Somatostatin: start intra-operatively and administered for seven (7) days after surgery at a dose of 6 mg/d
* Prophylactic use of antibiotics during 24h post-operatively
* Prophylactic use of Ranitidine as well as any PPI (proton pump inhibitor) is allowed to prevent peptic ulcer

Clinical evaluation and assessment criteria

* The number and type of POPF will be recorded according to the ISGPF guidelines and based on findings on day 3 (three) after surgery
* The number and type of postoperative complications will be recorded. The therapy-oriented severity grading system (TOSGS) of complications will be used and complications will be allocated to surgical (SSC) and non-surgical site (NSSC) complications
* The adequacy of the surgical resection margins (pR0) and the magnitude of the tumour-free resection margin (millimetres) will be monitored
* Postoperative length of hospital stay (LOS) will be registered

Patient randomization and registration procedure (randomization lists attached)

* This is a multicentric randomized controlled trial.
* Patient randomization will be done intra-operatively since a substantial number of patients could be dropped out intra-operatively because of the presence of unexpected intra-abdominal metastases at the time of surgery.
* Patient stratification will be performed for each centre and will be based on the diameter of the pancreatic duct. A pancreatic duct at the level of the surgical transsection margin measuring 3 millimetres or less in diameter is defined as being a "soft pancreas". A pancreatic duct measuring more than 3 millimetres is defined as a "hard pancreas".
* A prospective registration of following parameters will be performed: intra-operative diameter of the pancreatic duct at the surgical transection margin, diameter of the pancreas at the surgical transection margin, pancreatic tissue consistency assessed by the surgeon: soft vs. hard, post-operative pathology parameters.

Statistical analysis and sample size calculation based on a stratified design

* 40% of patients are expected to have a hard pancreas and 60% a soft pancreas.
* It is assumed that the magnitude of the effect of the intervention (PJ vs. PG) on the POPF rate, expressed as an odds ratio (OR), is similar in both strata.
* The needed sample size is calculated to have 80% power to detect a common odds ratio of 2.7. POPF rates of 12% and 20% are assumed after PJ within the hard and soft pancreas stratum respectively (yielding 4.8% and 8.4% after PG). Note that, given the unequal size strata, this leads to an expected POPF rate of 16.8% after PJ and 7% after PG (≈12% POPF overall).
* A 2-sided (with alpha=5%) Mantel-Haenszel test of OR=1 for stratified 2x2 tables is planned
* 168 patients are required per group (total patient population 336)
* Expected duration of recruitment: 3-4 years
* An interim analysis will be performed annually (i.e. after inclusion of 1/3 and 2/3 of the patients) to to allow early stop of the study (or accrual of patients in a specific treatment group) due to rejection of the null hypothesis. Using the O'Brien-Fleming method (O'Brien and Fleming 1979) results in respectively \|3.471\|, \|2.454\| and \|2.004\| as critical values for the Z-statistic at the three analysis moments. Otherwise stated, p-values are declared significant if \<.00052, \<0.0141 and \<0.0451 at respectively the first interim analysis, the second interim analysis and at the final analysis.
* Exact 95% confidence intervals will be calculated for the POPF and post-operative complication rates within each stratum. A stratified Mann-Whitney U test will be used for the TOSGS grading.

Translational research: optional Prognostic relevance of gene expression profiling in pancreatic cancer: analyses will be performed at UZ.Leuven/KU.Leuven (project coordinator B.Topal)

* Fresh tissue samples from pancreatic cancer and from non-tumoral pancreatic tissue will be stored in RNA-later (samples in 2 separate tubes; 5-10 volumes of RNA-later)
* Sample tubes will be transported (or picked up by the coördinator's research team), within 3 days from sampling, to be stored in -80°C for further analyses

Reduced Pancreatic Fistula Rate Following Pancreaticoduodenectomy: Trial on Pancreaticogastrostomy Versus Pancreaticojejunostomy

Reduced Postoperative Pancreatic Fistula Rate Following Pancreaticoduodenectomy; Multicentric Randomized Controlled Trial on Pancreaticogastrostomy vs. Pancreaticojejunostomy

Erasme ULB, Brussels

Jolimont, Brussels

St.Lucas, Brugge

General Hospital Groeninge

Université Catholique de Louvain

Clinique Saint Joseph, Liège

University Hospital, Antwerp

Jan Palfijn, Antwerp

St.Jan, Brugge

Monica, Deurne

Baki Topal

MD, PhD

Patients enrolled in the study will undergo contrast enhanced endoscopic ultrasound of the pancreas with Definity contrast after they have undergone their standard of care endoscopic ultrasound of the pancreas.

While the patient is still sedated from their EUS and before tissue sampling, the patient will receive a dose of Definity intravenously through their peripheral IV access after being agitated. The dose of Definity will be 10 microliters/kg given in one to two doses, and will not exceed 2cc.

Definity Contrast

James Hebert, M.D.

In the US, pancreas cancer is the fifth leading cause of cancer related deaths. It was estimated to have taken 36,800 lives in 2010. Unfortunately, curing pancreatic cancer requires surgical removal. Surgical removal of the pancreas is associated with high morbidity and mortality, as well as high rates of complications. One way to aid surgeons in removing pancreatic tumors is by providing them with a good idea of where the tumor is located and what surrounding structures are involved. This currently happens through many different modalities of imaging; usually computed tomography (CT) and endoscopic ultrasound. Even with these forms of imaging (and sometimes others), surgeons will occasionally open a patient and find that the tumor cannot be removed due to its involvement with surrounding structures.

One way to avoid potentially unnecessary procedures or to help a surgeon navigate this delicate procedure would be to provide more detailed information about the tumor. Several of the techniques currently used to image the body have rapidly advanced over recent years. Typical advancements come through better resolution of the images or contrast to enhance desired parts of the images. Ultrasound has not seen such a two pronged advance. Ultrasound has seen substantial advances in resolution to enhance picture quality, but contrast has not been used clinically to assess pancreatic masses whereas it is for cardiologists to use contrast to look at potential defects in the heart.

The contrast that is used with ultrasound is different from that of CT scans. CT scanners use a dye that can be potentially hazardous. This dye can lead to serious kidney damage in some patients. Ultrasound contrast, on the other hand, is made of small micro bubbles filled with a harmless gas. Because of the way ultrasound works, these micro bubbles reflect the sound waves differently than the surrounding tissue and thus provide contrast between normal tissue and abnormal tissue. The contrast used in this study, Definity, and is the same contrast used by Cardiologists.

The CE-EUS will be used for research purposes only and will not be used for any clinical decision making. The surgeon will be blinded to the results of the research CE-EUS. The investigators will compare the research pre-operative contrast enhanced endoscopic ultrasounds images with already completed standard-of-care CT scans, the actual pancreatic involvement seen in surgery and the pathology reports.

1. CT Scan of the abdomen - Standard Therapy

   a. The standard of care is that patients in question of pancreatic lesions undergo CT scanning. After a CT scan, if it appears that the pancreatic mass may be resectable, the standard protocol is to look at the pancreas while the patient is sedated with endoscopic ultrasound for diagnostic tissue sampling and further staging. For this reason, the endoscopist will not be blinded to the CT scan because it is the standard of care that they interpret the results of the EUS with that information.
2. Consent for Endoscopic Ultrasound (EUS) - Standard Therapy

   a. Before being sedated and having endoscopic ultrasound, all patients are informed about the risks of the procedure, alternatives, and what will be done. The patients who decide to undergo endoscopic ultrasound will sign a consent form. Our goal is to enroll 30 patients (This number is limited by both the amount of contrast received from Lantheus and the number of patients typically seen in a year. Ideally we will enroll as many as possible for the purposes of power).
3. Consent for Contrast Enhanced Endoscopic Ultrasound (CE-EUS) -- Performed exclusively for research purposes

   1. After the patient has been informed about the standard of care and signed a consent form, the patient will be asked if they wish to participate in an experimental study. If the patient is interested, they will be questioned about potential structural heart defects, congenital heart defects, recent worsening of heart or lung conditions, pulmonary hypertension, potential pregnancy, attempts to become pregnant, if they are nursing, or allergies to the contrast. If they report any of these relative contraindications, we will exclude them from participating in the study.
   2. If they are free of all of those relative contraindications, they will be provided information about the study (see included forms) and will be asked to sign a consent form as well as a HIPAA authorization.
4. EUS - Standard of Care

   1. At this point they will undergo an endoscopic ultrasound of the pancreas as per standard protocol. They will have a peripheral IV started by the endoscopic technician or nurse anesthetist. While the patient is being prepared, both research questionnaires (EUS and CE-EUS) will be filled out ahead of time with the exception of the findings, in order to reduce the time to complete the survey. The patient will be sedated in one of two ways. Either they will be consciously sedated with meperidine and midazolam under the surveillance of the attending gastroenterologist or they will have propofol based sedation under the surveillance of an anesthesiologist as per standard endoscopic ultrasound protocol.
   2. The patient will undergo their endoscopic ultrasound and video and images will be recorded.
5. EUS Questionnaire - Preformed exclusively for research purposes. Duration less than one minute.

   1. The endoscopist will then fill out a survey (see attached) to record their impressions of the tumor and the extent of its invasion into the vasculature. This should not take more than one minute. EUS criteria for vascular invasion will be loss of normal hyperechoic interface between the tumor and the vessel, irregular tumor and vessel interface, tumor within vessel lumen, vessel encasement, or collaterals with venous occlusion.
6. Decision about FNA - Standard of care, but important that it is done before CU-EUS a. If the endoscopist feels that FNA is warranted they will make the decision at this time.
7. CE-EUS - Experimental Procedure performed exclusively for research purposes

   a. Dosing of Contrast - procedure performed exclusively for research purposes i. While the patient is still sedated and before tissue sampling, the experimental aspect of the procedure will begin. At this time, they will receive a dose of Definity intravenously through their peripheral IV access after being agitated. The dose of Definity will be 10 microliters/kg given in one to two doses, and will not exceed 2cc. A saline flush will follow the injection of the contrast and a timer will be started. The remaining contrast will be properly disposed of in a sharps container.

   b. Recording of CE-EUS images - procedure performed exclusively for research purposes. Duration 3-4 minutes i. The endoscopist will perform an additional reading with the contrast and record a 3-4 minute segment for review later using the harmonic mode of the ultrasound probe at a mechanical index of 0.3. The mechanical index may need to be be optimized, however a previous study found 0.3 to be optimal. Aspects that will be analyzed later are sequence of filling (central vs peripheral), timing (arterial \[0-30s\], venous \[60-180s\], post-venous/equilibrium phase \[\>180s\]), pattern of perfusion (homogenous vs heterogenous, and with or without defect) and degree of venous washout. After the experimental portion of the procedure the endoscopist will fill out a form (see attached) to record their impressions of the characteristics of the tumor with contrast. The images will be saved for further comparison with the CT scan and the pathology results at a later time.
8. FNA - Standard of care (if previously decided upon)

   a. If it was determined after the normal EUS but before the CE-EUS that the patient needed tissue sampling, the patient will then undergo the sampling in the standard fashion. If the patient was not to receive tissue sampling, the exam would be over. When the exam is finished the endoscopist will fill out the remaining questionnaire while the patient recovers.
9. Patient recovery in Endoscopy Suite - Standard of Care
10. Patient transport to recovery room - Standard of Care

    1. After the patient recovers in the endoscopy room, the patient will be transported to the recovery room where they will be monitored for at least 30 minutes. The patient will be informed of the findings of their EUS per standard care. The patient will not be informed of the findings of CE-EUS as the significance is unknown.
    2. If an incidental lesion is found on EUS then the patient will undergo the appropriate follow-up for that lesion as per standard protocol. If an incidental finding is not apparent on EUS or CT, but happens to show up with the CU-EUS, the patient will be informed of the finding and its unknown significance.
11. Radiologist's Interpretation - Research purposes only

    a. After CE-EUS and EUS, the images will be randomly ordered and interpreted by a radiologist. An excel sheet will be made and the studies will be placed into three separate blocks in chronological order Participant 1-10, 11-20, and 21-30. In a separate column a random number generator will order the first block of 1-10's EUS into a random order for and then again a different random order for CE-EUS. The radiologist will fill out the attached questionnaire. The Surgeon will be blinded to these readings as they are for research purposes only and not the standard of care.
12. Surgery - Standard of Care with questionnaire after the procedure for research purposes

    a. The surgeon will record their impressions of the vascular involvement of the tumor on the attached questionnaire after the surgery.
13. Pathology review - Standard of care a. If the patient has pathology sent from surgery, the surgeon will label the vessels encompassed and the pathologist will report whether there was invasion into the vasculature. We will retrospectively review the pathology results of the surgery for comparison.

Contrast Enhanced Endoscopic Ultrasound for Vascular Involvement in Pancreatic Lesions

A Pilot Study of the Effects of Contrast Enhanced Endoscopic Ultrasound on Determining Vascular Involvement in Pancreatic Lesions

University of Vermont

Mackay-Page Professor of Surgery

Intestinal Neoplasms

Stomach Neoplasms

Intestinal Diseases

Stomach Diseases

Gastro-enteropancreatic Neuroendocrine Tumor

Stomach Cancer

Antineoplastic Agents

Anti-Infective Agents

Everolimus

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Everolimus 10mg(2x5mg)orally once daily until disease progression, unacceptable toxicity or consent withdrawal

Anna Koumarianou, Dr

The purpose of this study is to explore the efficacy and safety of everolimus administered as a first-line treatment in newly-diagnosed patients with advanced or inoperable Gastrointestinal (GI) or pancreatic neuroendocrine tumors.

Study of Everolimus Treatment in Newly-diagnosed Patients With Advanced Gastrointestinal Neuroendocrine Tumors

Phase II Multicenter Single-arm Study Evaluating the Safety and Efficacy of Everolimus as a First-line Treatment in Newly-diagnosed Patients With Advanced GI Neuroendocrine Tumors.

To determine the rate of PFS patients at 15 months of treatment.

Novartis

Hellenic Cooperative Oncology Group

Standard

Fanning

Shyam Varadarajulu, MD

Endoscopic Ultrasound (EUS)-guided biopsy is the most ideal technique for evaluating a growth in the pancreas. EUS-guided biopsies yield a definitive diagnosis in greater than 80% of cases. In 15-20% of the cases, a definitive diagnosis cannot be made despite multiple attempts. One of the reasons why a diagnosis cannot be made is due to the focal location of the cancer; i.e., the cancer can be situated in a corner of a big mass and the needle fails to sample the cancer cells. The fanning technique is a method where the needle moves in multiple directions within a mass and therefore there is a better chance of the cancer cells being sampled compared to the standard technique where the needle moves in only one direction. The diagnostic performance of both these techniques has not been compared in a randomized fashion.

Fanning technique: Fine Needle Aspiration (FNA) performed in multiple directions within a mass.

Standard technique: FNA performed in unidirectional fashion.

Standard Versus Fanning Techniques for Endoscopic Ultrasound-Fine Needle Aspiration (EUS-FNA)

Randomized Trial Comparing the Standard and Fanning Techniques for Fine Needle Aspiration of Pancreatic Mass Lesions at Endoscopic Ultrasound

The number of pancreatic masses that are correctly diagnosed with each needle type

Number of passes required to acquire tissue diagnosis using each needle type

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Natural History and Management of Von Hippel-Lindau (VHL) Associated Pancreatic Neuroendocrine Tumors	NCT04074135	VHL Pancreatic ... Von Hippel-Lind... Neuroendocrine ...	68-Gallium DOTA...	12 Years -	National Institutes of Health Clinical Center (CC)
Enucleation of Pancreatic Tumor by Blocking Abdominal Trunk and Superior Mesenteric Artery	NCT06164769	Tumor of Pancre... Surgical Blood ...	blocking both t...	14 Years - 70 Years	Zhejiang University
Evaluation of Image-guided Brushing of Pancreatic Cyst Wall in Diagnosis of Cystic Pancreatic Tumors	NCT01455311	Pancreatic Tumo...	EUS Guided Fine... EUS Guided Echo...	18 Years - 85 Years	H. Lee Moffitt Cancer Center and Research Institute
Natural History and Management of Von Hippel-Lindau (VHL) Associated Pancreatic Neuroendocrine Tumors	NCT04074135	VHL Pancreatic ... Von Hippel-Lind... Neuroendocrine ...	68-Gallium DOTA...	12 Years -	National Institutes of Health Clinical Center (CC)
Reduced Pancreatic Fistula Rate Following Pancreaticoduodenectomy: Trial on Pancreaticogastrostomy Versus Pancreaticojejunostomy	NCT00830778	Tumors	Pancreaticojeju... Pancreaticogast...	18 Years - 85 Years	University Hospital, Gasthuisberg
Contrast Enhanced Endoscopic Ultrasound for Vascular Involvement in Pancreatic Lesions	NCT01526590	Pancreatic Tumo...	Definity Contra...	18 Years -	University of Vermont
Evaluation of Image-guided Brushing of Pancreatic Cyst Wall in Diagnosis of Cystic Pancreatic Tumors	NCT01455311	Pancreatic Tumo...	EUS Guided Fine... EUS Guided Echo...	18 Years - 85 Years	H. Lee Moffitt Cancer Center and Research Institute
Study of Everolimus Treatment in Newly-diagnosed Patients With Advanced Gastrointestinal Neuroendocrine Tumors	NCT01648465	Gastrointestina... Pancreatic Tumo... Gastrointestina... Pancreatic Neur...	Everolimus	18 Years -	Hellenic Cooperative Oncology Group
Standard Versus Fanning Techniques for Endoscopic Ultrasound-Fine Needle Aspiration (EUS-FNA)	NCT01501903	Pancreatic Tumo...	Standard Fanning	19 Years - 90 Years	University of Alabama at Birmingham
Standard Versus Fanning Techniques for Endoscopic Ultrasound-Fine Needle Aspiration (EUS-FNA)	NCT01501903	Pancreatic Tumo...	Standard Fanning	19 Years - 90 Years	University of Alabama at Birmingham

Spots Global Cancer Trial Database for pancreatic tumors