Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2017-12-31

Brief Summary

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The purpose of this study is to determine whether duct-to-mucosa is better than invagination in pancreaticojejunostomy after pancreaticoduodenectomy. This single-centre, open, randomized controlled trail is conducted following ISGPF criteria for pancreatic fistula (PF). The duration of the study is supposed to start from Jan 5th 2012 and last to Dec 2014, until 100 or more cases are accessible. Patients diagnosed with pancreatic cancer, peri-ampullar carcinoma or other benign or malignant diseases which need to operate pancreaticoduodenectomy will be included. Main outcomes are pancreatic fistula rate, mortality, morbidity, reoperation and hospital stay. The investigators assumption that duct-to-mucosa is better than invagination.

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Detailed Description

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Conditions

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Pancreatic Neoplasms Biliary Tract Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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duct-to-mucosa

duct-to-mucosa technique is used for pancreaticojejunostomy after pancreaticoduodenectomy

Group Type EXPERIMENTAL

duct-to-mucosa

Intervention Type PROCEDURE

Internal stent

Intervention Type DEVICE

Internal stent may be used during pancreaticojejunostomy according to the situation of pancreatic duct and experience of the surgeon.

invagination

invagination technique is used for pancreaticojejunostomy after pancreaticoduodenectomy

Group Type ACTIVE_COMPARATOR

invagination

Intervention Type PROCEDURE

Internal stent

Intervention Type DEVICE

Internal stent may be used during pancreaticojejunostomy according to the situation of pancreatic duct and experience of the surgeon.

Interventions

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duct-to-mucosa

Intervention Type PROCEDURE

invagination

Intervention Type PROCEDURE

Internal stent

Internal stent may be used during pancreaticojejunostomy according to the situation of pancreatic duct and experience of the surgeon.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with pancreatic cancer or other diseases which need pancreaticoduodenectomy and pancreaticojejunostomy
* 18 to 80 y/o
* Operation-tolerated
* Informed consent

Exclusion Criteria

* History of gastrointestinal operation
* Pancreaticoduodenectomy is given up during operation
* Pancreatic duct is difficult to locate
* Patients require to exit from the study anytime

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No