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

NCT ID: NCT02149446

Last Updated: 2015-04-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-12-31

Brief 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.

Detailed Description

Resection of the distal pancreas is often done due to a localized tumor in the body or tail of the pancreas. During later years the mortality after pancreatic resections have been reduced but there still is a substantial risk of severe complications mainly due to leakage from the pancreatic division line which could lead to suffering, longer hospital stay, higher costs and sometimes death. Leakage from a tail resection is probably more common than thought of before. Frequencies of above 30% and even up to 60% have been reported.

The use of somatostatin to reduce the production of pancreatic juice or comparison between stapled division, suturing of the remaining part of the cut pancreas or covering it with glue or available surrounding tissue have not showed significant superiority for any of these methods except for a positive trend regarding the stapling technique. Staple line reinforcement with resorbable mesh has in some studies showed a both negative and positive effect on pancreatic fistula frequency. These studies have been small and non-randomized. A larger randomized single blinded study by Hamilton et al on the other hand showed a significant positive effect on pancreatic fistula frequency after distal pancreatic resection using an absorbable reinforcement device put on the stapler, when only regarding type B and C fistulas as defined by the ISGPF (International Study Group on Pancreatic Fistula) pancreatic leak grading system.

Although all these endeavors the problem of pancreatic fistulas remain and therefore all these operations are concluded with the deposit of one or more drains to the area of the cut pancreas.

There is therefore of importance to continue the work of reducing complications in high risk pancreatic surgery using scientific procedures of high quality as in blinded randomized controlled trials (RCT). The use of reinforced stapling techniques has been used in lung surgery and bariatric surgery to reduce air leakage and strengthen anastomoses. The material used is processed submucosa from the small bowel of the pig, produced by COOK© Medical to fit endoscopic staplers from Ethicon© or Covidien©.

After the promising result from Hamilton et al we plan to study if the reinforcement made by COOK© could reduce the frequency of pancreatic fistula after stapled distal pancreatic surgery in a single blinded RCT.

Conditions

Post Operative Pancreatic Fistula

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Surgisis reinforcement of staple line

The stapler used to divide the pancreas is reinforced with Surgisis (COOK Medical).

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

No reinforcement of staple line

The stapler used to divide the pancreas is not reinforced with any material

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Surgisis reinforcement of staple line

Eligibility Criteria

Inclusion Criteria

• Every patient eligible for pancreatic tail resection.

Exclusion Criteria

• Not able to read Swedish.
• Not able to understand or accept the concept.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sahlgrenska University Hospital

OTHER

Sponsor Role: collaborator

Lund University Hospital

OTHER

Sponsor Role: collaborator

University Hospital, Linkoeping

OTHER

Sponsor Role: collaborator

Norrlands University Hospital

OTHER

Sponsor Role: collaborator

Karolinska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

John Blomberg

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Blomberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dep of Surgical Gastoenterology, Karolinska University Hospital, Stockholm, Sweden

Locations

Dep of Surgical Gastroenterology, Karolinska University Hospital

Stockholm, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

John Blomberg, MD, PhD

Role: CONTACT

john.blomberg@karolinska.se

Marco Del Chiaro, MD, PhD

Role: CONTACT

marco.del.chiaro@ki.se

References

Wennerblom J, Ateeb Z, Jonsson C, Bjornsson B, Tingstedt B, Williamsson C, Sandstrom P, Ansorge C, Blomberg J, Del Chiaro M. Reinforced versus standard stapler transection on postoperative pancreatic fistula in distal pancreatectomy: multicentre randomized clinical trial. Br J Surg. 2021 Apr 5;108(3):265-270. doi: 10.1093/bjs/znaa113.

Reference Type: DERIVED

PMID: 33793753 (View on PubMed)

Other Identifiers

Surgisis-001

Identifier Type: -

Identifier Source: org_study_id