Reinforced Staple Line on Leak Rate in Distal Pancreatectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of a Reinforced Staple Line on Leak Rate in Distal Pancreatectomy

Conditions
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Pancreatic Neoplasms

Intervention / Treatment
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* Device: Mesh reinforced staple line (SEAMGUARD)
* Device: Stapled without mesh reinforcement (PER-STRIPS DRY)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stapled transection with mesh reinforcement<br>Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®) | Device: Mesh reinforced staple line (SEAMGUARD)<br>* Reinforce the pancreatic transaction with SEAMGUARD®<br>Device: Stapled without mesh reinforcement (PER-STRIPS DRY)<br>* Stapled without mesh reinforcement (PERI-STRIPS DRY®)<br>|
| No Intervention: Stapled transection without mesh reinforcement<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically Significant Postoperative Pancreatic Leak at Any Time as Defined by the ISGPF Pancreatic Leak Grading System | 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 | 100 days or removal of drain | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreas adenocarcinoma, Precancerous lesions of the pancreas (mucinous cystic neoplasms, IPMN), Pancreas neuroendocrine cancer