Pancreatic NeoplasmsNCT01359410

Reinforced Staple Line on Leak Rate in Distal Pancreatectomy

A study testing Mesh reinforced staple line (SEAMGUARD) and Stapled without mesh reinforcement (PER-STRIPS DRY) in people with Pancreatic Neoplasms, run by Washington University School of Medicine at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Pancreatic Neoplasms
What is being tested?: Mesh reinforced staple line (SEAMGUARD) and Stapled without mesh reinforcement (PER-STRIPS DRY)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 112 participants
Where: 1 siteUnited States
Study dates: Jun 2007to Sep 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Participants must be 18 years or older and able to give consent. Any patient undergoing a distal pancreatectomy, laparoscopic or open, will be eligible for randomization.
No exclusion is provided for primary diagnosis. In the event of a patient undergoing a planned resection of another organ or organs with only a possibility of a distal pancreatic resection (i.e. colectomy, hepatectomy, gastrectomy, nephrectomy), the patient will still be eligible for inclusion in the study. We expect that some patients will be randomized but not resected (ie metastasis identified). A few patients may not be stapled using the study device for technical reasons (ie the stapler does not fit). The data will be analyzed in an intent-to-treatment approach.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Effect of a Reinforced Staple Line on Leak Rate in Distal Pancreatectomy

The investigators propose a randomized, controlled trial of stapled pancreatic transection versus mesh reinforced stapled pancreatic transection. For the duration of the study period, participating surgeons will utilize a standardized staple technique. Either a reabsorbable polytrimethylene carbonate mesh (SEAMGUARD®) or reabsorbable strips of bovine pericardium (PERI-STRIPS DRY®) will be used to reinforce the stapled pancreatic transection line in the test group. In order to have a uniform test method, the investigators will utilize a laparoscopic stapling device for both open and laparoscopic procedures and a uniform staple size (4.8mm).

Read the detailed description

Pancreatic leak remains a significant cause of morbidity and extra cost following distal pancreatectomy. Historically, previous attempts to reduce the leak rate have met with limited success. To examine this problem the investigators propose a randomized, controlled trial of stapled pancreatic transection versus mesh reinforced stapled pancreatic transection. For the duration of the study period, participating surgeons will utilize a standardized staple technique. Either a reabsorbable polytrimethylene carbonate mesh (SEAMGUARD®) or reabsorbable strips of bovine pericardium (PERI-STRIPS DRY®) will be used to reinforce the stapled pancreatic transection line in the test group. In order to have a uniform test method, the investigators will utilize a laparoscopic stapling device for both open and laparoscopic procedures and a uniform staple size (4.8mm). A drain will be placed in the left upper quadrant at the time of resection. Drainage of the pancreatic resection bed is widely accepted and remains our current standard of care.

Conditions: Pancreatic Neoplasms
Being tested: Mesh reinforced staple line (SEAMGUARD), Stapled without mesh reinforcement (PER-STRIPS DRY)
Keywords: Pancreas adenocarcinoma, Precancerous lesions of the pancreas (mucinous cystic neoplasms, IPMN), Pancreas neuroendocrine cancer
Medical subject headings: Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mesh reinforced staple line (SEAMGUARD)Device
Reinforce the pancreatic transaction with SEAMGUARD®
Stapled without mesh reinforcement (PER-STRIPS DRY)Device
Stapled without mesh reinforcement (PERI-STRIPS DRY®)

Study groups in NCT01359410
Study group	Role	What they receive
Stapled transection with mesh reinforcement	Active comparator	Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®) Receives: Device: Mesh reinforced staple line (SEAMGUARD); Device: Stapled without mesh reinforcement (PER-STRIPS DRY)
Stapled transection without mesh reinforcement	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinically Significant Postoperative Pancreatic Leak at Any Time as Defined by the ISGPF Pancreatic Leak Grading System
- Identified as being a grade B or grade C fistula or any fistula that altered the patients' management in any way
- Determination of severity of pancreatic fistula was done using the ISGPF(International Study Group Pancreatic Fistula) leak/fistula/pancreatic occlusion failure
- Grade B: >3x normal serum amylase, often well clinical condition, yes/no specific treatment, negative/positive ultrasound/CT, usually persistent drainage (>3 weeks), yes/no signs of infection, yes/no readmission, no sepsis, no reoperation, no death related to fistula
- Grade C: >3x normal serum amylase, ill appearing/bad, requires specific treatment, positive ultrasound/CT, persistent drainage (>3 weeks), signs of infection, yes/no readmission, sepsis, reoperation, and death related to fistula
Measured: 100 days or removal of drain

Secondary outcomes (3)

Occurrence of Any Fistula as Defined by the ISGPF Pancreatic Leak Grading System
Measured: 100 days or removal of drain
Time to Drain Removal
Measured: 100 days or removal of drain
Number of Non-pancreatic Adverse Events
Measured: 100 days or removal of drain

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2007Sep 2011

First posted24 May 2011 (estimated)
Study startJun 2007
Primary completionJun 2011
Study completionSep 2011

Why it stopped: The 3rd interim analysis found superiority in the mesh reinforcement arm

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe 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: 112 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01359410
Sponsor's protocol ID: 06-1192
Status last verified: Mar 2017
First submitted: 20 May 2011
Last updated: 10 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Hawkins WG. To mesh or not to mesh, that is the question: comment on "Use of Seamguard to prevent pancreatic leak following distal pancreatectomy". Arch Surg. 2009 Oct;144(10):899. doi: 10.1001/archsurg.2009.34. No abstract available.
PubMed 19852096
Johnston FM, Cavataio A, Strasberg SM, Hamilton NA, Simon PO Jr, Trinkaus K, Doyle MB, Mathews BD, Porembka MR, Linehan DC, Hawkins WG. The effect of mesh reinforcement of a stapled transection line on the rate of pancreatic occlusion failure after distal pancreatectomy: review of a single institution's experience. HPB (Oxford). 2009 Feb;11(1):25-31. doi: 10.1111/j.1477-2574.2008.00001.x.
PubMed 19590620
Thaker RI, Matthews BD, Linehan DC, Strasberg SM, Eagon JC, Hawkins WG. Absorbable mesh reinforcement of a stapled pancreatic transection line reduces the leak rate with distal pancreatectomy. J Gastrointest Surg. 2007 Jan;11(1):59-65. doi: 10.1007/s11605-006-0042-6.
PubMed 17390188
Hamilton NA, Porembka MR, Johnston FM, Gao F, Strasberg SM, Linehan DC, Hawkins WG. Mesh reinforcement of pancreatic transection decreases incidence of pancreatic occlusion failure for left pancreatectomy: a single-blinded, randomized controlled trial. Ann Surg. 2012 Jun;255(6):1037-42. doi: 10.1097/SLA.0b013e31825659ef.
PubMed 22534422

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of a Reinforced Staple Line on Leak Rate in Distal Pancreatectomy
ClinicalTrials.gov ID: NCT01359410
Acronym / sponsor ID: 06-1192
Conditions: Pancreatic Neoplasms
Keywords: Pancreas adenocarcinoma, Precancerous lesions of the pancreas (mucinous cystic neoplasms, IPMN), Pancreas neuroendocrine cancer
Study type: Interventional
Recruitment status: TerminatedReason stopped: The 3rd interim analysis found superiority in the mesh reinforcement arm
Enrolment: 112 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Study start: Jun 2007
Primary completion: Jun 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 24 May 2011 (estimated)
Results: Posted 10 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Stapled transection with mesh reinforcement	Active comparator	Device: Mesh reinforced staple line (SEAMGUARD), Device: Stapled without mesh reinforcement (PER-STRIPS DRY)Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
Stapled transection without mesh reinforcement	No intervention	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Participants must be 18 years or older and able to give consent. Any patient undergoing a distal pancreatectomy, laparoscopic or open, will be eligible for randomization.
No exclusion is provided for primary diagnosis. In the event of a patient undergoing a planned resection of another organ or organs with only a possibility of a distal pancreatic resection (i.e. colectomy, hepatectomy, gastrectomy, nephrectomy), the patient will still be eligible for inclusion in the study. We expect that some patients will be randomized but not resected (ie metastasis identified). A few patients may not be stapled using the study device for technical reasons (ie the stapler does not fit). The data will be analyzed in an intent-to-treatment approach.

Key exclusion criteria (0 listed)

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
Mesh reinforced staple line (SEAMGUARD)Reinforce the pancreatic transaction with SEAMGUARD®	Device	Stapled transection with mesh reinforcement
Stapled without mesh reinforcement (PER-STRIPS DRY)Stapled without mesh reinforcement (PERI-STRIPS DRY®)	Device	Stapled transection with mesh reinforcement

Primary outcome

Clinically Significant Postoperative Pancreatic Leak at Any Time as Defined by the ISGPF Pancreatic Leak Grading System
Time frame: 100 days or removal of drain
* Identified as being a grade B or grade C fistula or any fistula that altered the patients' management in any way * Determination of severity of pancreatic fistula was done using the ISGPF(International Study Group Pancreatic Fistula) leak/fistula/pancreatic occlusion failure * Grade B: >3x normal serum amylase, often well clinical condition, yes/no specific treatment, negative/positive ultrasound/CT, usually persistent drainage (>3 weeks), yes/no signs of infection, yes/no readmission, no sepsis, no reoperation, no death related to fistula * Grade C: >3x normal serum amylase, ill appearing/bad, requires specific treatment, positive ultrasound/CT, persistent drainage (>3 weeks), signs of infection, yes/no readmission, sepsis, reoperation, and death related to fistula

3 secondary outcomes

Occurrence of Any Fistula as Defined by the ISGPF Pancreatic Leak Grading System
Time frame: 100 days or removal of drain
Time to Drain Removal
Time frame: 100 days or removal of drain
Number of Non-pancreatic Adverse Events
Time frame: 100 days or removal of drain

Results and safety

Results posted to the registry on 10 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stapled Transection With Mesh Reinforcement	54	54
Stapled Transection Without Mesh Reinforcement	46	46

Primary outcome: Clinically Significant Postoperative Pancreatic Leak at Any Time as Defined by the ISGPF Pancreatic Leak Grading System

Time frame: 100 days or removal of drain. Count of participants. Unit: Participants

Measure	Stapled Transection With Mesh Reinforcement n = 53	Stapled Transection Without Mesh Reinforcement n = 45
Value	1	11

Population analysed: (1) participant in the mesh reinforcement arm was not evaluable due to death and (1) participant in the non-mesh reinforcement arm was not evaluable due to death.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stapled Transection With Mesh Reinforcement	1 of 54 (1.9%)	3 of 54 (5.6%)	Not reported
Stapled Transection Without Mesh Reinforcement	11 of 46 (23.9%)	5 of 46 (10.9%)	Not reported

Limitations and caveats (from the sponsor): The investigators were unable to identify any complications directly due to the mesh materials. It is possible these complications are very rare and that the study did not include enough participants to potentially identify these potential harms.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19852096Hawkins WG. To mesh or not to mesh, that is the question: comment on "Use of Seamguard to prevent pancreatic leak following distal pancreatectomy". Arch Surg. 2009 Oct;144(10):899. doi: 10.1001/archsurg.2009.34. No abstract available.
Background: PubMed 19590620Johnston FM, Cavataio A, Strasberg SM, Hamilton NA, Simon PO Jr, Trinkaus K, Doyle MB, Mathews BD, Porembka MR, Linehan DC, Hawkins WG. The effect of mesh reinforcement of a stapled transection line on the rate of pancreatic occlusion failure after distal pancreatectomy: review of a single institution's experience. HPB (Oxford). 2009 Feb;11(1):25-31. doi: 10.1111/j.1477-2574.2008.00001.x.
Background: PubMed 17390188Thaker RI, Matthews BD, Linehan DC, Strasberg SM, Eagon JC, Hawkins WG. Absorbable mesh reinforcement of a stapled pancreatic transection line reduces the leak rate with distal pancreatectomy. J Gastrointest Surg. 2007 Jan;11(1):59-65. doi: 10.1007/s11605-006-0042-6.
Derived from this study: PubMed 22534422Hamilton NA, Porembka MR, Johnston FM, Gao F, Strasberg SM, Linehan DC, Hawkins WG. Mesh reinforcement of pancreatic transection decreases incidence of pancreatic occlusion failure for left pancreatectomy: a single-blinded, randomized controlled trial. Ann Surg. 2012 Jun;255(6):1037-42. doi: 10.1097/SLA.0b013e31825659ef.
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
Individual participant dataSharing planned: No

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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.

William Hawkins, M.D. principal investigator

Washington University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 0 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: stopped early, as of the sponsor's last update on 10 May 2017. 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 United States. 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?

Yes. Results are posted in the registry (first posted 10 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinically Significant Postoperative Pancreatic Leak at Any Time as Defined by the ISGPF Pancreatic Leak Grading System (time frame: 100 days or removal of drain). 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 NCT01359410, which also lists 4 linked publications.

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 10 May 2017.