Reinforced Staple Line on Leak Rate in Distal Pancreatectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01359410
First received: May 20, 2011
Last updated: August 9, 2013
Last verified: August 2013

May 20, 2011
August 9, 2013
June 2007
June 2011   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01359410 on ClinicalTrials.gov Archive Site
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Reinforced Staple Line on Leak Rate in Distal Pancreatectomy
Effect of a 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.

Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Pancreatic Neoplasms
  • 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®)
  • Active Comparator: Mesh reinforced staple line
    Mesh reinforced staple line (SEAMGUARD®)
    Intervention: Device: Mesh reinforced staple line (SEAMGUARD)
  • Active Comparator: Stapled without mesh reinforcement
    Stapled without mesh reinforcement (PERI-STRIPS DRY®)
    Intervention: Device: Stapled without mesh reinforcement (PER-STRIPS DRY)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
September 2011
June 2011   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01359410
06-1192
No
Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: William Hawkins, M.D. Washington University School of Medicine
Washington University School of Medicine
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP