NCT02149446

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 1, 2015

Status Verified

March 1, 2015

Enrollment Period

2.6 years

First QC Date

May 21, 2014

Last Update Submit

March 31, 2015

Conditions

Post Operative Pancreatic Fistula

Keywords

Left sided pancreatic resectionsDistal pancreatic resectionsReinforced staple linePost operative pancreatic fistula

Outcome Measures

Primary Outcomes (1)

  • Post operative pancreatic fistula (POPF), Y/N

    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

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Secondary Outcomes (6)

  • POPF healing time

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

  • POPF grade according to International Study Group of Pancreatic Fistula (ISGPF) grade A/B/C

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

  • Blood chemistry

    The first 7 days after operation

  • Morbidity

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.

  • Mortality

    < 90 days after the operation

  • +1 more secondary outcomes

Study Arms (2)

Surgisis reinforcement of staple line

EXPERIMENTAL

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

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

No reinforcement of staple line

NO INTERVENTION

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

Interventions

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

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

Also known as: Surgisis reinforcement of staple line
Surgisis reinforcement of staple line

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Every patient eligible for pancreatic tail resection.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep of Surgical Gastroenterology, Karolinska University Hospital

Stockholm, SE-141 86, Sweden

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33793753DERIVED

Study Officials

  • John Blomberg, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

John Blomberg, MD, PhD

CONTACT

john.blomberg@karolinska.se

Marco Del Chiaro, MD, PhD

CONTACT

marco.del.chiaro@ki.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

May 21, 2014

First Posted

May 29, 2014

Study Start

April 1, 2014

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

April 1, 2015

Record last verified: 2015-03

Locations

SE(1)