Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Pancreatic Neoplasms

Adenoma

Cysts

Cystadenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Cystic, Mucinous, and Serous

Pancreatic Cancer

Pancreatic Adenoma

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Ethanol

Anti-Infective Agents, Local

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

Blood and Lymph Conditions

Lymphadenopathy

Pancreatic Cyst

Adenoma, Islet Cell

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Lymphatic Diseases

Pancreatic Neuroendocrine Tumor

Gastrointestinal Agents

Pancrelipase

Pancreatin

Patient indicated for a first endoscopic ultrasound fine needle aspiration (EUS-FNA) for a pancreatic cyst,

Device: nCLE needle-based Confocal Laser Endomicroscopy

Endoscopic ultrasound fine needle aspiration

Divyesh V Sejpal, MD

This study focuses on four different lesions: pancreatic cysts, lymph nodes near the gastrointestinal tract, pancreatic masses and GIST tumors.

On one hand, the results obtained during previous studies are more advanced for the assessment of the diagnostic performance of Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system for Pancreatic cysts. Safety and technical feasibility have already been performed, and an interpretation criteria classification exists. On the other hand, results for pancreatic masses, Lymph nodes and GIST are less developed.

the objectives of the study are to

* Assess the diagnostic performance of the Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system in diagnosing masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract
* Define/Validate descriptive criteria of nCLE sequences in masses and cystic tu-mors of the pancreas, lymph nodes, submucosal lesions of the GI tract

The principle of needle-based Confocal Laser Endomicroscopy (nCLE) is to image organs within or adjacent to the GI or respiratory tracts by means of a miniprobe inserted through an endoscopic needle. The fundamental technology, as well as the principle of operation of nCLE, is substantially similar to pCLE.

endoscopic fine needles are used during EUS-FNA procedures to puncture solid organs such as the pancreas, in order to get tissue or fluid for diagnostic purposes. There are different calibers of endoscopic nee-dles used. The most commonly used calibers for EUS-FNA procedures are 22G, 19G, and 25G needles. The nCLE Confocal Miniprobe is compatible with the 19G-type needle only. It is expected to help to differentiate the different types of lesions, especially for cysts, leading to better patient management. Microscopic tissue information in real-time in vivo during an EUS-FNA procedure may allow better differentiation between mucinous and non-mucinous cysts for instance.

Clinical Registry of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract

Registry Trial for Clinical Evaluation of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract

* Assess the diagnostic performance of the Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system in diagnosing masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract (accuracy evaluation)
* Define/Validate descriptive criteria for nCLE sequences in the characterization of masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract (image interpretation criteria definition

* Evaluate the feasibility and safety of nCLE for the characterization of masses and cystic tumors of the pan-creas, lymph nodes, submucosal lesions of the GI tract (IE. number of patients with complications, number of adverse events)
* Build an atlas of images of nCLE sequences of masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract

Mauna Kea Technologies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
EUS-Guided Pancreatic Injection of Cyst (EPIC) Trial	NCT00233038	Pancreatic Cyst...	Ethanol injecti...	18 Years -	Massachusetts General Hospital
Clinical Registry of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract	NCT01770405	Pancreatic Cyst Pancreatic Neop... Pancreatic Aden... Pancreatic Canc... Pancreatic Isle... Lymph Node Mass Lymphadenopathy GIST	Endoscopic ultr...	18 Years -	Mauna Kea Technologies
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

Spots Global Cancer Trial Database for pancreatic adenoma