Effect of a Reinforced Staple Line on Leak Rate in Distal Pancreatectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Clinically Significant Postoperative Pancreatic Leak at Any Time as Defined by the ISGPF Pancreatic Leak Grading System
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Participant's were blinded to the results of the randomization for 6 weeks.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants must be 18 years or older and able to give consent. Any patient undergoing a distal pancreatectomy, laparoscopic or open, will be eligible for randomization.
- •No exclusion is provided for primary diagnosis. In the event of a patient undergoing a planned resection of another organ or organs with only a possibility of a distal pancreatic resection (i.e. colectomy, hepatectomy, gastrectomy, nephrectomy), the patient will still be eligible for inclusion in the study. We expect that some patients will be randomized but not resected (ie metastasis identified). A few patients may not be stapled using the study device for technical reasons (ie the stapler does not fit). The data will be analyzed in an intent-to-treatment approach.
Exclusion Criteria
- •None specified
Arms & Interventions
Stapled transection without mesh reinforcement
Stapled transection with mesh reinforcement
Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
Intervention: Mesh reinforced staple line (SEAMGUARD) (Device)
Stapled transection with mesh reinforcement
Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
Intervention: Stapled without mesh reinforcement (PER-STRIPS DRY) (Device)
Outcomes
Primary Outcomes
Clinically Significant Postoperative Pancreatic Leak at Any Time as Defined by the ISGPF Pancreatic Leak Grading System
Time Frame: 100 days or removal of drain
* Identified as being a grade B or grade C fistula or any fistula that altered the patients' management in any way * Determination of severity of pancreatic fistula was done using the ISGPF(International Study Group Pancreatic Fistula) leak/fistula/pancreatic occlusion failure * Grade B: \>3x normal serum amylase, often well clinical condition, yes/no specific treatment, negative/positive ultrasound/CT, usually persistent drainage (\>3 weeks), yes/no signs of infection, yes/no readmission, no sepsis, no reoperation, no death related to fistula * Grade C: \>3x normal serum amylase, ill appearing/bad, requires specific treatment, positive ultrasound/CT, persistent drainage (\>3 weeks), signs of infection, yes/no readmission, sepsis, reoperation, and death related to fistula
Secondary Outcomes
- Occurrence of Any Fistula as Defined by the ISGPF Pancreatic Leak Grading System(100 days or removal of drain)
- Time to Drain Removal(100 days or removal of drain)
- Number of Non-pancreatic Adverse Events(100 days or removal of drain)