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Does Reinforcement of the Staple Line in Left Pancreatectomy Reduce the Rate of Pancreatic Fistula?

NCT02149446 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-04-01

No results posted yet for this study

Summary

Dividing pancreas when performing left-sided resections opens the risk for leakage from the divided end of the pancreas. Pancreatic juices could have a severe effect on surrounding abdominal tissues with abscess formation producing systemic inflammation and potential lethal bleeding.

Studies have shown that reinforcement of the staple line when dividing pancreas could reduce the risk of leakage.

Surgisis (COOK Medical) a product already in use for staple line reinforcement in gastric and lung surgery could be used as a reinforcement when stapling pancreas in left sided resections.

In a prospective randomized trial we want to compare Surgisis reinforcement to no reinforcement of stapled division in left sided pancreatic resections.

Primary outcome is pancreatic fistula yes/no.

Conditions

  • Post Operative Pancreatic Fistula

Interventions

DEVICE

Surgisis (C-SLRA-ECH60) made by COOK Medical

Surgisis is extracellular matrix collagen made of the submucosal layer of pigs intestines. Surgisis is gradually remodeled, leaving behind organized tissue

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    collaborator OTHER

  • Lund University Hospital

    collaborator OTHER

  • University Hospital, Linkoeping

    collaborator OTHER

  • Norrlands University Hospital

    collaborator OTHER

  • Karolinska University Hospital

    lead OTHER

Principal Investigators

  • John Blomberg, MD, PhD · Dep of Surgical Gastoenterology, Karolinska University Hospital, Stockholm, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-11-30
Completion
2016-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02149446 on ClinicalTrials.gov