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NCT01481753 · ClinicalTrials.gov registry record · NA
Pancreaticoduodenectomy With or Without Braun Enteroenterostomy: Comparison of Postoperative Pancreatic Fistula and Delayed Gastric Emptying
A NA study, sponsored by Johns Hopkins University.
- Terminated
- Registry status
- NA
- Development phase
- 341
- Enrollment target
NCT01481753: Clinical Trial NA study, sponsored by Johns Hopkins University.
NCT01481753 is a NA study that was terminated before completion, run by Johns Hopkins University. The registered enrollment target is 341 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01481753, a NA study, was terminated before completion, sponsored by Johns Hopkins University.
- TERMINATED
- Registry status
- NA
- Development phase
- 341 participants
- Enrollment target
Study Summary
The investigators plan to perform a prospective randomized, head-to-head trial to test the hypothesis that the addition of Braun enteroenterostomy to standard pancreaticoduodenectomy (PD) reconstruction can decrease the rates of Postoperative Pancreatic Fistula (POPF) and/or Delayed Gastric Emptying (DGE).
Primary Outcome
patients will be assessed for post operative fistula and delayed gastric emptying during hospitalization and then interviewed at 90 days +/- 2 weeks from OR date to assess any unanticipated consequences after discharge. We are currently performing statistical analysis of outcome data on the first 100 consented whipple patients as outlined in Johns Hopkins Hospital (JHH)-approved Institutional Review Board (IRB) protocol.
Interventions
- PROCEDURE pancreaticoduodenectomy without Braun enteroenterostomy
- PROCEDURE Braun enteroenterostomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 341 participants |
| Start Date | 2009-12 |
| Est. Completion | 2016-09 |
| Phase | NA |
Why NCT01481753 stopped before completion
NCT01481753 is an interventional study that assigns participants to a tested intervention. The registered 341 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 (76% lower).
The record links to 0 conditions, and to 2 interventions - of which pancreaticoduodenectomy without Braun enteroenterostomy is the first listed.
NCT01481753 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01481753 about?
NCT01481753 is a clinical study titled "Pancreaticoduodenectomy With or Without Braun Enteroenterostomy: Comparison of Postoperative Pancreatic Fistula and Delayed Gastric Emptying". The investigators plan to perform a prospective randomized, head-to-head trial to test the hypothesis that the addition of Braun enteroenterostomy to standard pancreaticoduodenectomy (PD) reconstruction can decrease the rates of Postoperative Pancreatic Fistula (POPF) and/or Delayed Gastric Emptying...
What is the current status of trial NCT01481753?
This trial is currently terminated. It is a NA study. The enrollment target is 341 participants. The study started on 2009-12. Estimated completion is 2016-09.
What interventions are being tested in trial NCT01481753?
The interventions under investigation include: pancreaticoduodenectomy without Braun enteroenterostomy (PROCEDURE), Braun enteroenterostomy (PROCEDURE).
Who is sponsoring clinical trial NCT01481753?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01481753's enrollment target sits among peer trials
341 302nd of 2000 higher than 1,699 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
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