Reinforced Staple Line On Leak Rate In Distal Pancreatectomy

Study Overview

Reinforced Staple Line on Leak Rate in Distal Pancreatectomy

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).

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.

Pancreatic Neoplasms

DEVICE: Mesh reinforced staple line (SEAMGUARD)
DEVICE: Stapled without mesh reinforcement (PER-STRIPS DRY)

06-1192

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2011-05-20	Results First Submitted 2017-03-29	Last Update Submitted that met QC Criteria 2017-03-29
First Submitted that Met QC Criteria 2011-05-23	Results First Submitted that Met QC Criteria 2017-03-29	Last Update Posted (ACTUAL) 2017-05-10
First Posted (ACTUAL) 2011-05-24	Results First Posted 2017-05-10	Last Verified 2017-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Single

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Stapled transection with mesh reinforcement Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)	DEVICE: Mesh reinforced staple line (SEAMGUARD) Reinforce the pancreatic transaction with SEAMGUARD® DEVICE: Stapled without mesh reinforcement (PER-STRIPS DRY) Stapled without mesh reinforcement (PERI-STRIPS DRY®)
NO_INTERVENTION: Stapled transection without mesh reinforcement

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: Stapled transection with mesh reinforcement

Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)

DEVICE: Mesh reinforced staple line (SEAMGUARD)

Reinforce the pancreatic transaction with SEAMGUARD®

DEVICE: Stapled without mesh reinforcement (PER-STRIPS DRY)

Stapled without mesh reinforcement (PERI-STRIPS DRY®)

NO_INTERVENTION: Stapled transection without mesh reinforcement

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: William Hawkins, M.D., Washington University School of Medicine

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Hawkins WG. To mesh or not to mesh, that is the question: comment on "Use of Seamguard to prevent pancreatic leak following distal pancreatectomy". Arch Surg. 2009 Oct;144(10):899. doi: 10.1001/archsurg.2009.34. No abstract available.
Johnston FM, Cavataio A, Strasberg SM, Hamilton NA, Simon PO Jr, Trinkaus K, Doyle MB, Mathews BD, Porembka MR, Linehan DC, Hawkins WG. The effect of mesh reinforcement of a stapled transection line on the rate of pancreatic occlusion failure after distal pancreatectomy: review of a single institution's experience. HPB (Oxford). 2009 Feb;11(1):25-31. doi: 10.1111/j.1477-2574.2008.00001.x.
Thaker RI, Matthews BD, Linehan DC, Strasberg SM, Eagon JC, Hawkins WG. Absorbable mesh reinforcement of a stapled pancreatic transection line reduces the leak rate with distal pancreatectomy. J Gastrointest Surg. 2007 Jan;11(1):59-65. doi: 10.1007/s11605-006-0042-6.
Hamilton NA, Porembka MR, Johnston FM, Gao F, Strasberg SM, Linehan DC, Hawkins WG. Mesh reinforcement of pancreatic transection decreases incidence of pancreatic occlusion failure for left pancreatectomy: a single-blinded, randomized controlled trial. Ann Surg. 2012 Jun;255(6):1037-42. doi: 10.1097/SLA.0b013e31825659ef.

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