NCT03600584

Modified Duct-to-mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy

Modified One-layer Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy After Pancreaticoduodenectomy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 380 (estimated)
• Sponsor: Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare surgical outcomes of modified One-layer duct-to-mucosa versus invagination pancreaticojejunostomy after pancreatoduodenectomy

Detailed description

Duct-to-mucosa and invagination pancreaticojejunostomy are two most commonly used anastomotic techniques after pancreaticoduodenectomy, with comparable incidence rate of pancreatic fistula (PF). We modified the conventional two-layer duct-to-mucosa PJ into one-layer PJ. The aim of this study is to examine if the investigator's modified duct-to-mucosa PJ can reduce PF after PD when compared to invagination PJ. This trial is a single-center, randomized, controlled, patient- and observer- blinded study, whose primary aim is to assess whether a modified duct-to-mucosa PJ (trial group) is superior to an invagination PJ (control group), in terms of clinically relevant PF and other complications. A total of 380 patients, who are to undergo elective PD, will be recruited and randomized intraoperatively into either of the two groups. The primary efficacy endpoint is the incident rate of clinically relevant PF. Secondary outcome measures are: entry into adjuvant therapy, mortality, surgical complications, non-surgical complications, hospital stay. Patients will be followed up for 3 months. Statistical analysis will be based on the intention-to-treat population. The duration of the entire trial is estimated to be two years.

Conditions

• Pancreatic Fistula

Interventions

Type	Name	Description
PROCEDURE	Modified one-layer duct-to-mucosa Pancreaticojejunostomy	After the completion of the preparation of the remnant pancreas for reconstruction was performed. Modified one-layer duct-to-mucosa Pancreaticojejunostomy was performed.
PROCEDURE	Invagination pancreaticojejunostomy	After the completion of the preparation of the remnant pancreas for reconstruction was performed. Invagination Pancreaticojejunostomy was performed.

Timeline

• Start date: 2018-07-01
• Primary completion: 2019-12-01
• Completion: 2020-03-01
• First posted: 2018-07-26
• Last updated: 2018-07-26

Locations

1 site across 1 country: China