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| Sponsors and Collaborators: |
Massachusetts General Hospital American Society for Gastrointestinal Endoscopy |
| Information provided by: | Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00671463 |
Purpose
The purpose of this study is to investigate an intervention to prevent complications after pancreas surgery. The goal is to determine if placing a stent into the pancreatic duct before surgery will decrease or prevent leaking from the pancreatic duct after surgery. Leaks are common after pancreas surgery and can result in serious problems and post-operative pain. The study will compare two groups. One group will have the stent before surgery, and the other group will have standard pancreas surgery, no endoscopy, and no stent.
| Condition | Intervention |
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Pancreatic Surgery Pancreatic Duct Stenting Pancreatic Cancer Distal Pancreatectomy Pancreatic Diseases Pancreatic Cyst Pancreatic Ducts |
Procedure: Pancreatic duct stenting |
| MedlinePlus related topics: | Cancer Pancreatic Cancer Pancreatic Diseases |
| ChemIDplus related topics: | Pancrelipase Ultrase |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment |
| Official Title: | Leak Elimination After Pancreatic Stenting, a Randomized Controlled Trial |
| Estimated Enrollment: | 80 |
| Study Start Date: | April 2008 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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1: Experimental
Pre-operative pancreatic duct stenting
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Procedure: Pancreatic duct stenting
In the treatment arm, patients will have a pancreatic duct stent placed prior to having their distal pancreatectomy.
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2: No Intervention
Control group, no endoscopy and no stent pre-operatively
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Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |||||
| Massachusetts General Hospital | |||||
| Boston, Massachusetts, United States, 02114 | |||||
| Massachusetts General Hospital |
| American Society for Gastrointestinal Endoscopy |
| Study Director: | Field F Willingham, MD, MPH | MGH |
| Study Director: | Denise W Gee, MD | MGH |
| Study Director: | Sevdenur Cizginer, MD | MGH |
| Principal Investigator: | David W Rattner, MD | MGH |
| Principal Investigator: | William R Brugge, MD | MGH |
More Information
| Responsible Party: | Massachusetts General Hospital ( William Brugge, MD / Director of Endoscopy ) |
| Study ID Numbers: | 2007P000965 |
| First Received: | May 1, 2008 |
| Last Updated: | May 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00671463 |
| Health Authority: | United States: Institutional Review Board |
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