Clinical trialNATerminated
Reinforced Staple Line on Leak Rate in Distal Pancreatectomy
Effect of a Reinforced Staple Line on Leak Rate in Distal Pancreatectomy
- Outcome
- Stopped earlyThe 3rd interim analysis found superiority in the mesh reinforcement arm (Other)
- Phase
- NA
- Status
- Terminated
- Study type
- Interventional
- Start
- June 2007
- Expected end
- September 2011
- Enrollment
- 112 participants
- Sites
- 1
- Primary outcomes
- Clinically Significant Postoperative Pancreatic Leak at Any Time as Defined by the ISGPF Pancreatic Leak Grading System
- Sponsor
- Other
- Results posted
- 2017-05-10
- Last update
- 10 May 2017
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Brief summary public domain (ClinicalTrials.gov)
The investigators propose a randomized, controlled trial of stapled pancreatic transection versus mesh reinforced stapled pancreatic transection. For the duration of the study period, participating surgeons will utilize a standardized staple technique. Either a reabsorbable polytrimethylene carbonate mesh (SEAMGUARD®) or reabsorbable strips of bovine pericardium (PERI-STRIPS DRY®) will be used to reinforce the stapled pancreatic transection line in the test group. In order to have a uniform test method, the investigators will utilize a laparoscopic stapling device for both open and laparoscopic procedures and a uniform staple size (4.8mm).
Detailed description public domain (ClinicalTrials.gov)
Pancreatic leak remains a significant cause of morbidity and extra cost following distal pancreatectomy. Historically, previous attempts to reduce the leak rate have met with limited success. To examine this problem the investigators propose a randomized, controlled trial of stapled pancreatic transection versus mesh reinforced stapled pancreatic transection. For the duration of the study period, participating surgeons will utilize a standardized staple technique. Either a reabsorbable polytrimethylene carbonate mesh (SEAMGUARD®) or reabsorbable strips of bovine pericardium (PERI-STRIPS DRY®) will be used to reinforce the stapled pancreatic transection line in the test group. In order to have a uniform test method, the investigators will utilize a laparoscopic stapling device for both open and laparoscopic procedures and a uniform staple size (4.8mm). A drain will be placed in the left upper quadrant at the time of resection. Drainage of the pancreatic resection bed is widely accepted and remains our current standard of care.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Clinically Significant Postoperative Pancreatic Leak at Any Time as Defined by the ISGPF Pancreatic Leak Grading System [100 days or removal of drain]. Count Of Participants, Participants. Stapled Transection With Mesh Reinforcement (n=53): 1; Stapled Transection Without Mesh Reinforcement (n=45): 11.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Occurrence of Any Fistula as Defined by the ISGPF Pancreatic Leak Grading System [100 days or removal of drain]. Count Of Participants, Participants. Stapled Transection With Mesh Reinforcement (n=53): 21; Stapled Transection Without Mesh Reinforcement (n=45): 26.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Time to Drain Removal [100 days or removal of drain]. Median, days (95% Confidence Interval). Stapled Transection With Mesh Reinforcement (n=53): 9 (6 to 19); Stapled Transection Without Mesh Reinforcement (n=45): 17 (7 to 40).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Non-pancreatic Adverse Events [100 days or removal of drain]. Number, non-pancreatic adverse events. Stapled Transection With Mesh Reinforcement (n=54): 21; Stapled Transection Without Mesh Reinforcement (n=46): 28.