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

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ClinicalTrials.gov Identifier: NCT02149446
Recruitment Status : Unknown
Verified March 2015 by John Blomberg, Karolinska University Hospital.
Recruitment status was:  Recruiting
First Posted : May 29, 2014
Last Update Posted : April 1, 2015
Sponsor:
Collaborators:
Sahlgren´s University Hospital
Lund University Hospital
University Hospital, Linkoeping
Norrlands University Hospital
Information provided by (Responsible Party):
John Blomberg, Karolinska University Hospital

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.


Condition or disease Intervention/treatment Phase
Post Operative Pancreatic Fistula Device: Surgisis (C-SLRA-ECH60) made by COOK Medical Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Pancreas Fistula After Distal Pancreatic Resection: Prevention and Treatment in a Randomized Controlled Trial
Study Start Date : April 2014
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: Surgisis reinforcement of staple line
The stapler used to divide the pancreas is reinforced with Surgisis (COOK Medical).
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
Other Name: Surgisis reinforcement of staple line

No Intervention: No reinforcement of staple line
The stapler used to divide the pancreas is not reinforced with any material



Primary Outcome Measures :
  1. Post operative pancreatic fistula (POPF), Y/N [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]
    Pancreatic amylase concentration in any post operative drains. Fistula is diagnosed if pancreatic amylase > 3 times the upper normal limit of pancreatic amylase in plasma on post operative day 3 or later


Secondary Outcome Measures :
  1. POPF healing time [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]
    Time from diagnosis to healed pancreatic fistula

  2. POPF grade according to International Study Group of Pancreatic Fistula (ISGPF) grade A/B/C [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]
    Worst POPF grade registered during the observation period.

  3. Blood chemistry [ Time Frame: The first 7 days after operation ]
    During the first 7 post operative days each participant will have daily measurements taken from blood samples regarding C-reactive protein, white blood count, pancreatic plasma amylase and from drain fluid regarding pancreas amylase. The participants daily drain volume will also be measured.

  4. Morbidity [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks. ]
    According to Clavien scoring

  5. Mortality [ Time Frame: < 90 days after the operation ]
  6. Hospital stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks. ]
    Number of days



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02149446


Contacts
Contact: John Blomberg, MD, PhD john.blomberg@karolinska.se
Contact: Marco Del Chiaro, MD, PhD marco.del.chiaro@ki.se

Locations
Sweden
Dep of Surgical Gastroenterology, Karolinska University Hospital Recruiting
Stockholm, Sweden, SE-141 86
Principal Investigator: John Blomberg, MD, PhD         
Sponsors and Collaborators
Karolinska University Hospital
Sahlgren´s University Hospital
Lund University Hospital
University Hospital, Linkoeping
Norrlands University Hospital
Investigators
Principal Investigator: John Blomberg, MD, PhD Dep of Surgical Gastoenterology, Karolinska University Hospital, Stockholm, Sweden

Responsible Party: John Blomberg, MD PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT02149446     History of Changes
Other Study ID Numbers: Surgisis-001
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015

Keywords provided by John Blomberg, Karolinska University Hospital:
Left sided pancreatic resections
Distal pancreatic resections
Reinforced staple line
Post operative pancreatic fistula

Additional relevant MeSH terms:
Fistula
Pancreatic Fistula
Pathological Conditions, Anatomical
Digestive System Fistula
Digestive System Diseases
Pancreatic Diseases
Pancrelipase
Gastrointestinal Agents