Pancreaticoduodenectomy With or Without Braun Enteroenterostomy: Comparison of Postoperative Pancreatic Fistula and Delayed Gastric Emptying

Delayed Gastric Emptying Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01481753
• Other study ID #: NA_00021168
• Status: Terminated
• Phase: N/A
• First received: November 10, 2011
• Last updated: March 2, 2017
• Start date: December 2009
• Est. completion date: September 2016

Study information

• Verified date: March 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 341
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delayed Gastric Emptying
• Fistula
• Gastroparesis
• Pancreatic Fistula
• Postoperative Pancreatic Fistula

Intervention

Procedure:
• pancreaticoduodenectomy without Braun enteroenterostomy
no Braun enteroenterostomy has been added to standard pancreaticoduodenectomy; pancreaticoduodenectomy without Braun enteroenterostomy
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decreased rates of pancreatic fistula in surgeries adding Braun enteroenterostomy	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.	patients will be followed during hospital stay and interviewed at 90 days +/- 2 weeks post surgery
Secondary	Reduced incidence of delayed gastric emptying in patients with Braun enteroenterostomy	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	patients will be followed during hospital stay and interviewed at 90 days +/- 2 weeks post surgery