Suspended

Randomised Controlled Trail of Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy After Pancreaticoduodenectomy

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What is being tested

duct-to-mucosa

+ Internal stent

+ invagination

ProcedureDevice
Who is being recruted

Biliary Tract Diseases+7

+ Digestive System Diseases

+ Digestive System Neoplasms

From 18 to 80 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2012
See protocol details

Summary

Principal SponsorTingBo Liang
Study ContactXue-Li Bai, Ph.D.More contacts
Last updated: January 26, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01695447
Principal SponsorTingBo Liang
Study ContactXue-Li Bai, Ph.D.More contacts
Last updated: January 26, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Biliary Tract DiseasesDigestive System DiseasesDigestive System NeoplasmsEndocrine System DiseasesEndocrine Gland NeoplasmsNeoplasmsNeoplasms by SitePancreatic DiseasesBiliary Tract NeoplasmsPancreatic Neoplasms

Criteria

4 inclusion criteria required to participate
18 to 80 y/o
Informed consent
Operation-tolerated
Patients diagnosed with pancreatic cancer or other diseases which need pancreaticoduodenectomy and pancreaticojejunostomy
4 exclusion criteria prevent from participating
History of gastrointestinal operation
Pancreatic duct is difficult to locate
Pancreaticoduodenectomy is given up during operation
Patients require to exit from the study anytime

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

Active Comparator
invagination technique is used for pancreaticojejunostomy after pancreaticoduodenectomy

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

the Second Affiliated Hospital, School of Medicine, Zhejiang Universtiy

Hangzhou, ChinaOpen the Second Affiliated Hospital, School of Medicine, Zhejiang Universtiy in Google Maps
SuspendedOne Study Center