- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01057355
Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms
September 17, 2014 updated by: Mark Topazian, Mayo Clinic
Pancreatic cysts are common, and some pancreas cysts have malignant potential.
Usual treatment of these cysts is either observation or surgical removal of part or all of the pancreas.
Minimally invasive treatment via endoscopy has been described, using endoscopic ultrasound (EUS) guided ethanol injections.
Such studies exclude cysts that communicate with the main pancreatic duct, to avoid burning the main pancreatic duct with ethanol.
In this study, pancreas cysts communicating with the main pancreas duct are treated with ethanol via endoscopic retrograde cholangiopancreatography (ERCP) and/or EUS.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
Subjects will undergo EUS and/or ERCP as outpatients.
For cysts shown to communicate with the main pancreas duct, a balloon catheter will be placed in the main pancreatic duct via ERCP.
The balloon catheter will isolate the cyst from the main pancreatic duct, allowing ethanol injections of the cyst.
A pancreatic duct stent will be placed in some patients, requiring repeat endoscopy for removal at another time.
Study Type
Interventional
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Presence of a pancreatic cystic lesion, at least 2 cm in maximum diameter
- Cyst may communicate, or definitely communicates, with the pancreatic duct (based on prior CT, MR, ERCP, or EUS images)
- Treatment of the cystic lesion is desired due to symptoms or concern for subsequent malignancy
- Age at least 18 years
- Able to give informed consent
- Surgical treatment has been considered and a surgical consultation offered to the patient, OR the subject's cyst does not meet consensus criteria for surgical resection. (Current consensus criteria for resection are one or more of the following: cyst is symptomatic, ≥ 3 cm in diameter, contains a mural nodule, cytology of cyst fluid is positive for malignancy, or main pancreatic duct diameter is > 6 mm.)
Exclusion Criteria:
- Known or suspected pregnancy, or nursing
- History of pancreatitis within 3 months prior to study endoscopy procedures
- Cyst has a primarily microcystic architecture on EUS
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Cyst ethanol lavage
Subjects receiving the study intervention
|
Lavage of cyst with 80% ethanol
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence of adverse events requiring treatment or hospitalization
Time Frame: 3 days, 30 days
|
3 days, 30 days
|
Decrease in volume of the pancreatic cyst by cross-sectional imaging studies (CT or MR) performed before and after treatment
Time Frame: 6 months, 12 months
|
6 months, 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (ACTUAL)
June 1, 2013
Study Completion (ACTUAL)
June 1, 2013
Study Registration Dates
First Submitted
January 26, 2010
First Submitted That Met QC Criteria
January 26, 2010
First Posted (ESTIMATE)
January 27, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
September 19, 2014
Last Update Submitted That Met QC Criteria
September 17, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Neoplasms
- Pancreatic Neoplasms
- Neoplasms, Cystic, Mucinous, and Serous
- Physiological Effects of Drugs
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Central Nervous System Depressants
- Ethanol
Other Study ID Numbers
- 009-004705
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pancreatic Neoplasms
-
Memorial Sloan Kettering Cancer CenterRecruitingPancreatic Cancer | Pancreatic Cancer Metastatic | Pancreatic Cancer Stage IV | Metastatic Pancreatic Carcinoma | Metastatic Pancreatic Adenocarcinoma | Pancreatic Carcinoma | Metastatic Pancreatic Cancer | Pancreatic Cancer Non-resectable | Metastatic Pancreatic Ductal Adenocarcinoma | Pancreatic Carcinoma... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CelgeneWithdrawnPancreatic Ductal Adenocarcinoma | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedPancreatic Adenocarcinoma | Resectable Pancreatic Cancer | Stage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic Cancer | Poorly Differentiated Malignant Neoplasm | Undifferentiated Pancreatic CarcinomaUnited States
-
University of UtahNovartis PharmaceuticalsRecruitingMetastatic Pancreatic Carcinoma | Unresectable Pancreatic Carcinoma | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage II Pancreatic CancerUnited States
-
The First Affiliated Hospital with Nanjing Medical...RecruitingLocally Advanced Pancreatic Adenocarcinoma | Metastatic Pancreatic Cancer | Pancreatic NeoplasmChina
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)WithdrawnStage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic Cancer
-
National Cancer Institute (NCI)CompletedStage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
OHSU Knight Cancer InstituteOregon Health and Science University; Celgene CorporationCompletedPancreatic Adenocarcinoma | Resectable Pancreatic CarcinomaUnited States
-
University of OxfordNational Institute for Health Research, United Kingdom; ImunonWithdrawnPancreatic Cancer Metastatic | Pancreatic Ductal Adenocarcinoma | Pancreatic Cancer Stage IV | Pancreatic Cancer Non-resectableUnited Kingdom
-
Mayo ClinicNational Cancer Institute (NCI)CompletedAdvanced Pancreatic Carcinoma | Metastatic Pancreatic Carcinoma | Stage II Pancreatic Cancer AJCC v8 | Stage III Pancreatic Cancer AJCC v8 | Stage IV Pancreatic Cancer AJCC v8 | Unresectable Pancreatic Carcinoma | Pancreatic Neoplasm | Locally Advanced Pancreatic CarcinomaUnited States
Clinical Trials on EUS and/or ERCP with ethanol injections of pancreatic cyst
-
Hillel Yaffe Medical CenterUnknown
-
AdventHealthRecruiting
-
University of Auckland, New ZealandNorth Shore Hospital, New Zealand; Waikato Hospital; Gut Cancer Foundation, New...Not yet recruitingIntraductal Papillary Mucinous Neoplasm of PancreasNew Zealand
-
Indiana UniversityCompletedPancreatic Cyst | Pancreatic Intraductal Papillary-Mucinous Neoplasm | Cystadenoma, Mucinous | Papillary Mucinous Cystadenoma, Borderline MalignancyUnited States
-
Chess Mobile HealthNational Institute on Drug Abuse (NIDA); Western Michigan UniversityNot yet recruitingSubstance-Related Disorders
-
Changhai HospitalRecruitingAbdominal Pain | Pancreatitis, Chronic | Exocrine Pancreatic Insufficiency | Cholangiopancreatography, Endoscopic RetrogradeChina
-
Indiana University School of MedicineTerminatedPancreas NeoplasmsUnited States
-
Hospital Universitari Vall d'Hebron Research InstituteRecruitingChronic Subdural HematomaSpain