Reinforced Staple Line on Leak Rate in Distal Pancreatectomy - Full Text View

Purpose

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	Intervention	Phase
Pancreatic Neoplasms	Device: Mesh reinforced staple line (SEAMGUARD) Device: Stapled without mesh reinforcement (PER-STRIPS DRY)	Phase 0


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Effect of a Reinforced Staple Line on Leak Rate in Distal Pancreatectomy

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Pancreatic Cancer

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

To determine if mesh reinforced pancreatic transaction (via SEAMGUARD® or PERI-STRIPS DRY®) decreases the incidence of pancreatic leak following distal pancreatectomy. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Reinforcing the stapled pancreatic transection line with a reabsorbable polytrimethylene carbonate mesh will significantly decrease the amount of amylase rich fluid present in the drain "pancreatic leak" and the duration (number of days) amylase rich fluid is present in the drain.

To compare the two types of mesh (SEAMGUARD® or PERI-STRIPS DRY®)to determine the the incidence of pancreatic leak following distal pancreatectomy.


Enrollment:	105
Study Start Date:	June 2007
Study Completion Date:	September 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Mesh reinforced staple line Mesh reinforced staple line (SEAMGUARD®)	Device: Mesh reinforced staple line (SEAMGUARD) Reinforce the pancreatic transaction with SEAMGUARD®
Active Comparator: Stapled without mesh reinforcement Stapled without mesh reinforcement (PERI-STRIPS DRY®)	Device: Stapled without mesh reinforcement (PER-STRIPS DRY) Stapled without mesh reinforcement (PERI-STRIPS DRY®)

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	May 20, 2011
Last Updated:	August 9, 2013
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 27, 2016