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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:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01359410
First received: May 20, 2011
Last updated: March 29, 2017
Last verified: March 2017
  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
Pancreatic Neoplasms Device: Mesh reinforced staple line (SEAMGUARD) Device: Stapled without mesh reinforcement (PER-STRIPS DRY)

Study Type: Interventional
Study Design: 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

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

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 ]

Enrollment: 112
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: 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

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)
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
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:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Results First Received: March 29, 2017
Last Updated: March 29, 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

ClinicalTrials.gov processed this record on September 21, 2017