Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01359410 · ClinicalTrials.gov registry record · NA
Reinforced Staple Line on Leak Rate in Distal Pancreatectomy
A NA study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- NA
- Development phase
- 112
- Enrollment target
NCT01359410: Clinical Trial NA study, sponsored by Washington University School of Medicine.
NCT01359410 is a NA study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 112 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01359410, a NA study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- NA
- Development phase
- 112 participants
- Enrollment target
Study 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).
Primary Outcome
* 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 se
Interventions
- DEVICE Mesh reinforced staple line (SEAMGUARD)
- DEVICE Stapled without mesh reinforcement (PER-STRIPS DRY)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2007-06 |
| Est. Completion | 2011-09 |
| Phase | NA |
Why NCT01359410 stopped before completion
NCT01359410 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Mesh reinforced staple line (SEAMGUARD) is the first listed.
NCT01359410 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01359410 about?
NCT01359410 is a clinical study titled "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 carbonat...
What is the current status of trial NCT01359410?
This trial is currently terminated. It is a NA study. The enrollment target is 112 participants. The study started on 2007-06. Estimated completion is 2011-09.
What interventions are being tested in trial NCT01359410?
The interventions under investigation include: Mesh reinforced staple line (SEAMGUARD) (DEVICE), Stapled without mesh reinforcement (PER-STRIPS DRY) (DEVICE).
Who is sponsoring clinical trial NCT01359410?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01359410's enrollment target sits among peer trials
112 813th of 2000 higher than 1,185 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04511013 · 112 participants · Phase 2
A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases
- NCT04551560 · 112 participants · NA
Stress and Congestive Heart Failure
- NCT04872166 · 112 participants · Phase 1
A Study of BTX-A51 in People With Advanced Solid Tumor and Breast Cancer
- NCT05024773 · 112 participants · Phase 3
Study of ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia