Reinforced Staple Line on Leak Rate in Distal Pancreatectomy
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Pancreatic Neoplasms |
Procedure: Mesh reinforced staple line Procedure: Stapled without mesh reinforcement |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Effect of a Reinforced Staple Line on Leak Rate in Distal Pancreatectomy |
- To determine if mesh reinforced pancreatic transaction (via SEAMGUARD® or PERI-STRIPS DRY®) decreases the incidence of pancreatic leak following distal pancreatectomy. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Reinforcing the stapled pancreatic transection line with a reabsorbable polytrimethylene carbonate mesh will significantly decrease the amount of amylase rich fluid present in the drain "pancreatic leak" and the duration (number of days) amylase rich fluid is present in the drain.
To compare the two types of mesh (SEAMGUARD® or PERI-STRIPS DRY®)to determine the the incidence of pancreatic leak following distal pancreatectomy.
| Enrollment: | 105 |
| Study Start Date: | June 2007 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Mesh reinforced staple line
Mesh reinforced staple line (SEAMGUARD®)
|
Procedure: Mesh reinforced staple line
Reinforce the pancreatic transaction with SEAMGUARD®
|
|
Active Comparator: Stapled without mesh reinforcement
Stapled without mesh reinforcement (PERI-STRIPS DRY®)
|
Procedure: Stapled without mesh reinforcement
Stapled without mesh reinforcement (PERI-STRIPS DRY®)
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria: None specified
Contacts and Locations| United States, Missouri | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| Principal Investigator: | William Hawkins, M.D. | Washington University School of Medicine |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01359410 History of Changes |
| Other Study ID Numbers: | 06-1192 |
| Study First Received: | May 20, 2011 |
| Last Updated: | March 12, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Washington University School of Medicine:
|
Pancreas adenocarcinoma Precancerous lesions of the pancreas (mucinous cystic neoplasms, IPMN) Pancreas neuroendocrine cancer |
Additional relevant MeSH terms:
|
Neoplasms Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013