Modified Duct-to-mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-31

Study Completion Date

2020-03-31

Brief Summary

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

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Detailed Description

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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

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Pancreatic Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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One-layer duct-to-mucosa Group

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

Group Type EXPERIMENTAL

Modified one-layer duct-to-mucosa Pancreaticojejunostomy

Intervention Type PROCEDURE

After the completion of the preparation of the remnant pancreas for reconstruction was performed. Modified one-layer duct-to-mucosa Pancreaticojejunostomy was performed.

Invagination Group

Invagination pancreaticojejunostomy is used after pancreaticoduodenectomy.

Group Type ACTIVE_COMPARATOR

Invagination pancreaticojejunostomy

Intervention Type PROCEDURE

After the completion of the preparation of the remnant pancreas for reconstruction was performed. Invagination Pancreaticojejunostomy was performed.

Interventions

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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.

Intervention Type PROCEDURE

Invagination pancreaticojejunostomy

After the completion of the preparation of the remnant pancreas for reconstruction was performed. Invagination Pancreaticojejunostomy was performed.

Intervention Type PROCEDURE

Eligibility Criteria

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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。

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No