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

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Pancreas Fistula After Distal Pancreatic Resection: Prevention and Treatment in a Randomized Controlled Trial

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 Summary:

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 qua
Sponsor: Karolinska University Hospital

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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.
  • 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.
  • Morbidity [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks. ]
    According to Clavien scoring
  • Mortality [ Time Frame: < 90 days after the operation ]
  • Hospital stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks. ]
    Number of days


Original Secondary Outcome: Same as current

Information By: Karolinska University Hospital

Dates:
Date Received: May 21, 2014
Date Started: April 2014
Date Completion: December 2016
Last Updated: March 31, 2015
Last Verified: March 2015