We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Reinforced Staple Line on Leak Rate in Distal Pancreatectomy

This study has been terminated.
(The 3rd interim analysis found superiority in the mesh reinforcement arm)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01359410
First Posted: May 24, 2011
Last Update Posted: May 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
May 20, 2011
May 24, 2011
March 29, 2017
May 10, 2017
May 10, 2017
June 2007
June 2011   (Final data collection date for primary outcome measure)
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
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 ]

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.

Complete list of historical versions of study NCT01359410 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
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
Not Provided
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
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: Stapled transection with mesh reinforcement
    Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
    Interventions:
    • Device: Mesh reinforced staple line (SEAMGUARD)
    • Device: Stapled without mesh reinforcement (PER-STRIPS DRY)
  • No Intervention: Stapled transection without mesh reinforcement

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
112
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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01359410
06-1192
Yes
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
Plan to Share IPD: 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
March 2017

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