Reinforced Staple Line on Leak Rate in Distal Pancreatectomy
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ClinicalTrials.gov Identifier: NCT01359410 |
Recruitment Status
:
Terminated
(The 3rd interim analysis found superiority in the mesh reinforcement arm)
First Posted
: May 24, 2011
Results First Posted
: May 10, 2017
Last Update Posted
: May 10, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pancreatic Neoplasms | Device: Mesh reinforced staple line (SEAMGUARD) Device: Stapled without mesh reinforcement (PER-STRIPS DRY) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 112 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Masking Description: | Participant's were blinded to the results of the randomization for 6 weeks. |
Primary Purpose: | Treatment |
Official Title: | Effect of a Reinforced Staple Line on Leak Rate in Distal Pancreatectomy |
Study Start Date : | June 2007 |
Actual Primary Completion Date : | June 2011 |
Actual Study Completion Date : | September 2011 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Stapled transection with mesh reinforcement
Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
|
Device: Mesh reinforced staple line (SEAMGUARD)
Reinforce the pancreatic transaction with SEAMGUARD®
Device: Stapled without mesh reinforcement (PER-STRIPS DRY)
Stapled without mesh reinforcement (PERI-STRIPS DRY®)
|
No Intervention: Stapled transection without mesh reinforcement |
- 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
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01359410
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 |
Additional Information:
Publications:
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 |
First Posted: | May 24, 2011 Key Record Dates |
Results First Posted: | May 10, 2017 |
Last Update Posted: | May 10, 2017 |
Last Verified: | March 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | Yes | |
Device Product Not Approved or Cleared by U.S. FDA: | No | |
Pediatric Postmarket Surveillance of a Device Product: | No | |
Product Manufactured in and Exported from the U.S.: | No |
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:
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |