Pancreaticoduodenectomy With or Without Braun Enteroenterostomy: Comparison of Postoperative Pancreatic Fistula and Delayed Gastric Emptying
This study is currently recruiting participants.
Verified March 2013 by Johns Hopkins University
Sponsor:
Johns Hopkins University
Information provided by (Responsible Party):
Christopher L. Wolfgang, MD, PhD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01481753
First received: November 10, 2011
Last updated: March 27, 2013
Last verified: March 2013
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Postoperative Pancreatic Fistula Delayed Gastric Emptying |
Procedure: pancreaticoduodenectomy without Braun enteroenterostomy Procedure: Braun enteroenterostomy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Johns Hopkins University:
Primary Outcome Measures:
- Decreased rates of pancreatic fistula in surgeries adding Braun enteroenterostomy [ Time Frame: patients will be followed during hospital stay and interviewed at 90 days +/- 2 weeks post surgery ] [ Designated as safety issue: No ]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 JHH-approved IRB protocol.
Secondary Outcome Measures:
- Reduced incidence of delayed gastric emptying in patients with Braun enteroenterostomy [ Time Frame: patients will be followed during hospital stay and interviewed at 90 days +/- 2 weeks post surgery ] [ Designated as safety issue: No ]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 JHH-approved IRB protocol
| Estimated Enrollment: | 304 |
| Study Start Date: | December 2009 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Braun arm
patients received Braun enteroenterostomy
|
Procedure: Braun enteroenterostomy
addition of Braun enteroenterostomy (side-to-side anastomosis between the afferent and efferent loops of the gastrojejunostomy) to standard PD reconstruction can decrease the rates of POPF and/or DGE, improving the perioperative outcome of patients undergoing PD.
|
|
Active Comparator: Non Braun Arm
Patients do not receive a Braun enteroenterostomy
|
Procedure: pancreaticoduodenectomy without Braun enteroenterostomy
no Braun enteroenterostomy has been added to standard pancreaticoduodenectomy; pancreaticoduodenectomy without Braun enteroenterostomy
Other Name: No Braun
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients undergoing pancreaticoduodenectomy surgery at Johns Hopkins Hospital
Exclusion Criteria:
- Pregnant women
- Patients under the age of 18
- adults lacking ability to consent,
- patients scheduled for laparoscopic whipple surgery
- non-english-speakers, and
- prisoners
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01481753
Locations
| United States, Maryland | |
| Johns Hopkins Hospital | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Christopher L Wolfgang, MD, PhD 410-502-4194 cwolfga2@jhmi.edu | |
| Contact: Mary B Hodgin, MS, BSN 410-614-8817 mhodgin1@jhmi.edu | |
| Principal Investigator: Christopher L Wolfgang, MD, PhD | |
Sponsors and Collaborators
Johns Hopkins University
Investigators
| Principal Investigator: | Christopher L Wolfgang, MD, PhD | Johns Hopkins University |
More Information
No publications provided
| Responsible Party: | Christopher L. Wolfgang, MD, PhD, Principal Investigator, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT01481753 History of Changes |
| Other Study ID Numbers: | NA_00021168 |
| Study First Received: | November 10, 2011 |
| Last Updated: | March 27, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Fistula Pancreatic Fistula Gastroparesis Pathological Conditions, Anatomical Digestive System Fistula Digestive System Diseases |
Pancreatic Diseases Stomach Diseases Gastrointestinal Diseases Paralysis Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013