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Effect of a Reinforced Staple Line on Leak Rate in Distal Pancreatectomy


N/A
18 Years
N/A
Not Enrolling
Both
Pancreatic Neoplasms

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Trial Information

Effect of a Reinforced Staple Line on Leak Rate in Distal Pancreatectomy


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

To determine if mesh reinforced pancreatic transaction (via SEAMGUARD® or PERI-STRIPS DRY®) decreases the incidence of pancreatic leak following distal pancreatectomy.

Outcome Description:

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.

Outcome Time Frame:

1 day

Safety Issue:

No

Principal Investigator

William Hawkins, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

06-1192

NCT ID:

NCT01359410

Start Date:

June 2007

Completion Date:

September 2011

Related Keywords:

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

Name

Location
Washington University School of Medicine Saint Louis, Missouri  63110