Modified Duct-to-mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy

Nanjing Medical University

Status: Unknown

Conditions: Pancreatic Fistula

Treatments: Procedure: Invagination pancreaticojejunostomy; Procedure: Modified one-layer duct-to-mucosa Pancreaticojejunostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03600584

JSPH-PC-201801

Details and patient eligibility

About

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

Full 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.

Enrollment: 380 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written Informed consent obtained；
• Both sexes between 18 and 80 years old；
• Patients scheduled to elective open pancreaticoduodenectomy.

Exclusion criteria

• Patients with ASA score >=4;
• Patients who had a previous pancreatic operation;
• Patients with an immunodeficiency;
• Patients who underwent an emergency operation;
• Pregnant patients；
• Patients who was found that pancreaticoduodenectomy was not suitable。

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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380 participants in 2 patient groups

One-layer duct-to-mucosa Group

Experimental group

Description:

Modified one-layer duct-to-mucosa pancreaticojejunostomy is used after pancreaticoduodenectomy.

Treatment:

Procedure: Modified one-layer duct-to-mucosa Pancreaticojejunostomy

Invagination Group

Active Comparator group

Description:

Invagination pancreaticojejunostomy is used after pancreaticoduodenectomy.

Treatment:

Procedure: Invagination pancreaticojejunostomy