Reinforced Staple Line on Leak Rate in Distal Pancreatectomy

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ClinicalTrials.gov Identifier: NCT01359410

Recruitment Status : Terminated (The 3rd interim analysis found superiority in the mesh reinforcement arm)

First Posted : May 24, 2011

Results First Posted : May 10, 2017

Last Update Posted : May 10, 2017

Sponsor:

Information provided by (Responsible Party):

Washington University School of Medicine

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Pancreatic Neoplasms	Device: Mesh reinforced staple line (SEAMGUARD) Device: Stapled without mesh reinforcement (PER-STRIPS DRY)	Not Applicable

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 (Clinical Trial)
Actual Enrollment :	112 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Masking Description:	Participant's were blinded to the results of the randomization for 6 weeks.
Primary Purpose:	Treatment
Official Title:	Effect of a Reinforced Staple Line on Leak Rate in Distal Pancreatectomy
Study Start Date :	June 2007
Actual Primary Completion Date :	June 2011
Actual Study Completion Date :	September 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

Occurrence of Any Fistula as Defined by the ISGPF Pancreatic Leak Grading System [ Time Frame: 100 days or removal of drain ]
Time to Drain Removal [ Time Frame: 100 days or removal of drain ]
Number of Non-pancreatic Adverse Events [ Time Frame: 100 days or removal of drain ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01359410

Locations


United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

Investigators


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

More Information

Additional Information:

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT01359410 History of Changes
Other Study ID Numbers:	06-1192
First Posted:	May 24, 2011 Key Record Dates
Results First Posted:	May 10, 2017
Last Update Posted:	May 10, 2017
Last Verified:	March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No


Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		Yes
Device Product Not Approved or Cleared by U.S. FDA:		No
Pediatric Postmarket Surveillance of a Device Product:		No
Product Manufactured in and Exported from the U.S.:		No

Keywords provided by Washington University School of Medicine:


Pancreas adenocarcinoma Precancerous lesions of the pancreas (mucinous cystic neoplasms, IPMN) Pancreas neuroendocrine cancer

Additional relevant MeSH terms:


Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms	Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases

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