Post Operative Pancreatic FistulaNCT02149446
Does Reinforcement of the Staple Line in Left Pancreatectomy Reduce the Rate of Pancreatic Fistula?
A study testing Surgisis (C-SLRA-ECH60) made by COOK Medical in people with Post Operative Pancreatic Fistula, run by Karolinska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Pancreatic Fistula
- What is being tested?
- Surgisis (C-SLRA-ECH60) made by COOK Medical
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Every patient eligible for pancreatic tail resection.
Who cannot join
- Not able to read Swedish.
- Not able to understand or accept the concept.
Trial locations and contacts
1 site in 1 country.
John Blomberg, MD, PhD contact
Marco Del Chiaro, MD, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Dep of Surgical Gastroenterology, Karolinska University Hospital
Stockholm, SE-141 86
John Blomberg, MD, PhD
About this study
Official title: Pancreas Fistula After Distal Pancreatic Resection: Prevention and Treatment in a Randomized Controlled Trial
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.
Read more
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.
Read the 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
- Being tested
- Surgisis (C-SLRA-ECH60) made by COOK Medical
- Keywords
- Left sided pancreatic resections, Distal pancreatic resections, Reinforced staple line, Post operative pancreatic fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgisis (C-SLRA-ECH60) made by COOK MedicalDevice
Also called Surgisis reinforcement of staple line
Surgisis is extracellular matrix collagen made of the submucosal layer of pigs intestines. Surgisis is gradually remodeled, leaving behind organized tissue
| Study group | Role | What they receive |
|---|---|---|
| Surgisis reinforcement of staple line | Experimental | The stapler used to divide the pancreas is reinforced with Surgisis (COOK Medical). Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes (6)
POPF healing time
Time from diagnosis to healed pancreatic fistula
Measured: 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
Worst POPF grade registered during the observation period.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Blood chemistry
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.
Measured: The first 7 days after operation
Morbidity
According to Clavien scoring
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Mortality
Measured: < 90 days after the operation
Hospital stay
Number of days
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Operative Pancreatic FistulaStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Lund University Hospital, University Hospital, Linkoeping, Norrlands University Hospital
- Responsible party
- Principal investigator, John Blomberg, Karolinska University Hospital
- Investigators
- John Blomberg, MD, PhD, Principal investigator, Dep of Surgical Gastoenterology, Karolinska University Hospital, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149446
- Sponsor's protocol ID
- Surgisis-001
- Status last verified
- Mar 2015
- First submitted
- 21 May 2014
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33793753
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreas Fistula After Distal Pancreatic Resection: Prevention and Treatment in a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02149446
- Acronym / sponsor ID
- Surgisis-001
- Conditions
- Post Operative Pancreatic Fistula
- Keywords
- Left sided pancreatic resections, Distal pancreatic resections, Reinforced staple line, Post operative pancreatic fistula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Lund University Hospital, University Hospital, Linkoeping, Norrlands University Hospital
- Study start
- Apr 2014
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 29 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgisis reinforcement of staple line | Experimental | Device: Surgisis (C-SLRA-ECH60) made by COOK MedicalThe stapler used to divide the pancreas is reinforced with Surgisis (COOK Medical). |
| No reinforcement of staple line | No intervention | –The stapler used to divide the pancreas is not reinforced with any material |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Every patient eligible for pancreatic tail resection.
Key exclusion criteria (2 listed)
- Not able to read Swedish.
- Not able to understand or accept the concept.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgisis (C-SLRA-ECH60) made by COOK MedicalAlso: Surgisis reinforcement of staple lineSurgisis is extracellular matrix collagen made of the submucosal layer of pigs intestines. Surgisis is gradually remodeled, leaving behind organized tissue | Device | Surgisis reinforcement of staple line |
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
6 secondary outcomes
POPF healing time
Time frame: 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
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Blood chemistry
Time frame: The first 7 days after operation
Morbidity
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
- Derived from this study: PubMed 33793753Wennerblom 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Blomberg, MD, PhD contact
Marco Del Chiaro, MD, PhD contact
John Blomberg, MD, PhD principal investigator
Dep of Surgical Gastoenterology, Karolinska University Hospital, Stockholm, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgisis (C-SLRA-ECH60) made by COOK Medical in people with Post Operative Pancreatic Fistula, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John Blomberg, MD, PhD (john.blomberg@karolinska.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02149446, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.