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

• Conditions: Pancreatic Cancer

• Registration Number: NCT01926717
• Lead Sponsor: Chengyi Sun

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2013-08-19
• Study First Submitted QC: 2013-08-20
• Study First Posted: 2013-08-21
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-06
• Last Update Posted: 2016-03-08
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The secretion function of the pancreas	Participants will be followed for overall 3 year after surgery

Secondary Outcome Measures

Name	Time	Method
The function of biliary tract	Participants will be followed for overall 3 year after surgery

Trial Locations

Locations (1)

The Affiliated Hospital of Guiyang Medical College; 🇨🇳 Guiyang, Guizhou, China