Reinforced Staple Line on Leak Rate in Distal Pancreatectomy

NCT01359410 | Terminated Results DMC FDA Device

• 1 other identifier: 06-1192
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Pancreatic Neoplasms

Keywords

Pancreas adenocarcinoma; Precancerous lesions of the pancreas (mucinous cystic neoplasms, IPMN); Pancreas neuroendocrine cancer

Outcome Measures

Primary Outcomes (1)

• 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

  100 days or removal of drain

Secondary Outcomes (3)

• Occurrence of Any Fistula as Defined by the ISGPF Pancreatic Leak Grading System

  100 days or removal of drain

• Time to Drain Removal

  100 days or removal of drain

• Number of Non-pancreatic Adverse Events

  100 days or removal of drain

Study Arms (2)

Stapled transection with mesh reinforcement

ACTIVE COMPARATOR

Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)

Device: Mesh reinforced staple line (SEAMGUARD); Device: Stapled without mesh reinforcement (PER-STRIPS DRY)

Stapled transection without mesh reinforcement

NO INTERVENTION

Interventions

Mesh reinforced staple line (SEAMGUARD) DEVICE

Reinforce the pancreatic transaction with SEAMGUARD®

Stapled transection with mesh reinforcement

Stapled without mesh reinforcement (PER-STRIPS DRY) DEVICE

Stapled without mesh reinforcement (PERI-STRIPS DRY®)

Stapled transection with mesh reinforcement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (4)

• 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.

  PMID: 19852096 BACKGROUND

• 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.

  PMID: 19590620 BACKGROUND

• 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.

  PMID: 17390188 BACKGROUND

• 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.

  PMID: 22534422 DERIVED

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: William Hawkins, M.D.
• Organization: Washington University School of Medicine

hawkinsw@wustl.edu

314-362-7046

Study Officials

• William Hawkins, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant's were blinded to the results of the randomization for 6 weeks.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2011
• First Posted: May 24, 2011
• Study Start: June 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: September 1, 2011
• Last Updated: May 10, 2017
• Results First Posted: May 10, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)