Delayed Gastric Emptying, Postoperative Pancreatic Fistula
Conditions
Brief 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).
Interventions
PROCEDUREpancreaticoduodenectomy without Braun enteroenterostomy
no Braun enteroenterostomy has been added to standard pancreaticoduodenectomy; pancreaticoduodenectomy without Braun enteroenterostomy
PROCEDUREBraun 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.
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decreased rates of pancreatic fistula in surgeries adding Braun enteroenterostomy | patients will be followed during hospital stay and interviewed at 90 days +/- 2 weeks post surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduced incidence of delayed gastric emptying in patients with Braun enteroenterostomy | patients will be followed during hospital stay and interviewed at 90 days +/- 2 weeks post surgery | 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 |
Countries
United States
Outcome results
None listed