Neoplasms

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Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Cysts

Pancreatic Cyst

Cystadenocarcinoma

Cystadenoma

Cystadenoma, Mucinous

Cystadenocarcinoma, Mucinous

Neoplasms, Cystic, Mucinous, and Serous

Pancreatic Intraductal Neoplasms

Pathological Conditions, Anatomical

Pancreatic Diseases

Gastrointestinal Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenoma

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Endocrine System Diseases

Adenocarcinoma of the Appendix

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Central Nervous System Depressants

Paclitaxel

Albumin-Bound Paclitaxel

Ethanol

Tubulin Modulators

Antimitotic Agents

Anti-Infective Agents, Local

Pancreatic cyst injection via Endoscopic Ultrasound (EUS)of 98% Ethanol with Paclitaxel (dose determined in relation to cyst size \& amount of fluid aspirated from the cyst.

98% Ethanol & Paclitaxel injection

John M. DeWitt, MD

The purpose of this study is to track outcomes and complications of patients at IUMC referred by physicians for EUS-guided pancreatic cyst ablation. This information is essential in order to disseminate future published information to physicians about this technique. A database will be created to track these patients undergoing an already scheduled/planned procedure. Phone calls at selected intervals will be made following the procedure to track any complications that occur

Pancreatic cysts represent a wide spectrum of lesions. Many cysts are uniformly benign (pseudocysts) or have negligible malignant potential (serous cystadenomas). However, others represent premalignant (i.e. intraductal papillary mucinous neoplasms (IPMNs) or mucinous cystadenomas \[MCN\]), or malignant (i.e. invasive IPMNs or mucinous cystadenocarcinomas) tumors. Management of pancreatic cysts is challenging but surgery is generally recommended for cysts that are symptomatic, premalignant (except possibly branch duct IPMNs) or demonstrate malignancy by imaging features and/or biopsy. However, even in experienced hospitals, surgical resection or enucleation of pancreatic cystic tumors is associated with significant perioperative morbidity and mortality rates of 20-40% and up to 2%, respectively.

Endoscopic Ultrasound (EUS)-Guided Ablation of Pancreatic Cysts

1. Patients will undergo EUS-guided cyst ablation with ethanol +/- paclitaxel as indicated for their scheduled procedure. 2. Patients will return 3 months after initial ablation for a repeat EUS, and ablation will be repeated if cyst size is \>10mm in diameter. 3. CT or MRI imaging will be performed 3 months after the second procedure to assess for cyst resolution.

Indiana University

Director Endoscopic Ultrasound

Cystadenoma, Serous

Gastrointestinal Agents

Pancrelipase

Pancreatin

For patients with indeterminate cystic lesions of the pancreas, in addition to routine diagnostic investigations, patients participating in the study will undergo needle based confocal laser endomicroscopy (using the AQ-flex 19 probe - Mauna Kea Technologies, Paris France) at the time of their endoscopic ultrasound.

Needle-based Confocal Laser Endomicroscopy (nCLE)

AQ-Flex 19 probe (Mauna Kea Technologies, Paris)

Steve Pereira, PhD FRCP

A multicentre phase II study to determine the safety and efficacy of EUS-guided nCLE in patients with suspected cystic tumours of the pancreas in whom endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is clinically indicated. Patients will be recruited sequentially to undergo nCLE as part of their routine diagnostic evaluation, followed by standard surveillance. This part of the study will recruit 60 patients.

A multicentre phase II study to determine the safety and efficacy of EUS-guided nCLE in patients with suspected cystic tumours of the pancreas in whom endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is clinically indicated. Patients will be recruited sequentially to undergo nCLE as part of their routine diagnostic evaluation, followed by standard surveillance. This part of the study will recruit 60 patients. The study also includes a feasibility study to evaluate the role of intraoperative nCLE in the diagnosis and staging of pancreatic tumours. This part of the study will recruit a further 20 patients.

Primary endpoint:

Assess the diagnostic performance of the Cellvizio nCLE system in the characterization of pancreatic cysts, compared to standard diagnostic modalities.

Secondary endpoints:

* Assess the safety and efficacy of EUS-nCLE.
* Assess the impact of the Cellvizio nCLE system on the management of patients with pancreatic cysts.
* Develop and validate interpretation criteria for nCLE in the pancreas.
* Assess the diagnostic performance of nCLE in characterising and staging pancreatic tumours intraoperatively.

A Phase II MULTICENTRE Trial of Needle Based Laser Confocal Endomicroscopy of Cystic and Solid Tumours of the Pancreas

Assess the diagnostic accuracy of the Cellvizio nCLE system for diagnosing cystic lesions of the pancreas, compared to standard diagnostic modalities

Record the number of participants with an adverse event due to EUS-nCLE

Develop and validate interpretation criteria for nCLE in the pancreas

Assess the diagnostic accuracy of nCLE in defining the margins and extent of pancreatic tumours intraoperatively

Cambridge University Hospitals NHS Foundation Trust

University College, London

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Endoscopic Ultrasound (EUS)-Guided Ablation of Pancreatic Cysts	NCT01643460	Pancreatic Cyst Pancreatic Intr... Cystadenoma, Mu... Papillary Mucin...	98% Ethanol & P...	18 Years -	Indiana University
A Phase II MULTICENTRE Trial of Needle Based Laser Confocal Endomicroscopy of Cystic and Solid Tumours of the Pancreas	NCT02523170	Pancreatic Cyst Serous Cystaden... Intraductal Pap... Cystadenoma, Mu...	AQ-Flex 19 prob...	18 Years -	University College, London
A Phase II MULTICENTRE Trial of Needle Based Laser Confocal Endomicroscopy of Cystic and Solid Tumours of the Pancreas	NCT02523170	Pancreatic Cyst Serous Cystaden... Intraductal Pap... Cystadenoma, Mu...	AQ-Flex 19 prob...	18 Years -	University College, London

Spots Global Cancer Trial Database for cystadenoma, mucinous