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

NCT01926717 | Unknown DMC

• 1 other identifier: GYGDWK-02
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

Single Roux-y of Pancreaticojejunostomy-choledochojejunostomy

Outcome Measures

Primary Outcomes (1)

• The secretion function of the pancreas

  Participants will be followed for overall 3 year after surgery

Secondary Outcomes (1)

• The function of biliary tract

  Participants will be followed for overall 3 year after surgery

Other Outcomes (1)

• The relief of abdominal pain symptom

  Participants will be followed for overall 3 year after surgery

Study Arms (2)

Single Roux-y of Pancreaticojejunostomy-choledochojejunostomy

Pancreaticoduodenectomy

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pancreatic cancer

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chengyi Sun: lead

Study Sites (1)

The Affiliated Hospital of Guiyang Medical College

Guiyang, Guizhou, 550004, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Hepatobiliary Surgery

Study Record Dates

• First Submitted: August 19, 2013
• First Posted: August 21, 2013
• Study Start: December 1, 2010
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 8, 2016

Record last verified: 2016-03

Locations

CN (1)