A Comparative Clinical Research On Single Roux-en-Y And Traditional Roux-en-Y Of Pancreaticojejunostomy-choledochojejunostomy For Treatment Of Obstruction Of Pancreatic Duct And Bile Duct

Study Overview

A Comparative Clinical Research on Single Roux-en-Y and Traditional Roux-en-Y of Pancreaticojejunostomy-choledochojejunostomy For Treatment of Obstruction of Pancreatic Duct and Bile Duct

This study is being done to learn more about how different surgery procedures bring back the quality of life.After removing the small intestine at least 20cm in patients with pancreatic cancer, Some patients develop problems because they are disorder their digestive system, such as cramping, heartburn,vomiting.

N/A

Pancreatic Cancer

GYGDWK-02

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-08-19	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-03-06
First Submitted that Met QC Criteria 2013-08-20	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-03-08
First Posted (ESTIMATED) 2013-08-21	Results First Posted N/A	Last Verified 2016-03

Study Plan

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

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Single Roux-y of Pancreaticojejunostomy-choledochojejunostomy
: Pancreaticoduodenectomy

Primary Outcome Measures	Measure Description	Time Frame
The secretion function of the pancreas		Participants will be followed for overall 3 year after surgery

Secondary Outcome Measures	Measure Description	Time Frame
The function of biliary tract		Participants will be followed for overall 3 year after surgery

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
30 Years

Accepts Healthy Volunteers:

Patient 30 years of age or older
Pathologically confirmed pancreatic cancer (biopsy may be performed at our institution)
No evidence of metastases(a)
decide performe Roux-en-Y(b)
single Roux-en-Y reconstruction is technically feasible(c)
Patients will be registered and consent obtained, if the surgeon believes there is no evidence of metastases. If metastatic disease is identified at the time of operation, the patient will not be randomized.
Patients will be conditionally enrolled, and consent obtained, if the surgeon believes the patient may need a sngle Roux-en-Y at the time of operation. If a sngle Roux-en-Y is not performed, the patient will not be randomized.
the surgeon feels that the single Roux-en-Y is not technically feasible at the time of operation,the patients will be excluded. This may be due to prior abdominal surgery, anatomic variants, or anything else at the surgeon's discretion.

Not expected to be able to provide follow-up over 2 years (due to geographic or other limitations)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record