Reinforced Staple Line on Leak Rate in Distal Pancreatectomy

Not Applicable

Terminated

• Conditions: Pancreatic Neoplasms
• Interventions: Device: Mesh reinforced staple line (SEAMGUARD); Device: Stapled without mesh reinforcement (PER-STRIPS DRY)

• Registration Number: NCT01359410
• Lead Sponsor: Washington University School of Medicine

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2011-05-20
• Study First Submitted QC: 2011-05-23
• Study First Posted: 2011-05-24
• Primary Completion: 2011-06
• Study Completion: 2011-09
• Status Verified: 2017-03
• Results First Submitted: 2017-03-29
• Results First Submitted QC: 2017-03-29
• Last Update Submitted: 2017-03-29
• Results First Posted: 2017-05-10
• Last Update Posted: 2017-05-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 112

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.

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Exclusion Criteria

None specified

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stapled transection with mesh reinforcement	Mesh reinforced staple line (SEAMGUARD)	Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
Stapled transection with mesh reinforcement	Stapled without mesh reinforcement (PER-STRIPS DRY)	Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)

Primary Outcome Measures

Name	Time	Method
Clinically Significant Postoperative Pancreatic Leak at Any Time as Defined by the ISGPF Pancreatic Leak Grading System	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States