Clinical trial NCT02149446: Does Reinforcement of the Staple Line in Left Pancreatectomy Reduce the Rate of Pancreatic Fistula?
Official title: Pancreas Fistula After Distal Pancreatic Resection: Prevention and Treatment in a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Operative Pancreatic Fistula
Keywords: Left sided pancreatic resections
Distal pancreatic resections
Reinforced staple line
Post operative pancreatic fistula
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
name: Lund University Hospital
name: University Hospital, Linkoeping
name: Norrlands University Hospital
First posted: 2014-05-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Post operative pancreatic fistula (POPF), Y/N
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes:
measure: POPF healing time
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: POPF grade according to International Study Group of Pancreatic Fistula (ISGPF) grade A/B/C
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Blood chemistry
timeFrame: The first 7 days after operation
measure: Morbidity
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
measure: Mortality
timeFrame: < 90 days after the operation
measure: Hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Dep of Surgical Gastroenterology, Karolinska University Hospital
Study officials:
affiliation: Dep of Surgical Gastoenterology, Karolinska University Hospital, Stockholm, Sweden
name: John Blomberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.