Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy
Pancreatic Neoplasms - Biliary Tract Neoplasms
Conditions: official terms
Biliary Tract Neoplasms - Neoplasms - Pancreatic Neoplasms
Study Type
Study Phase
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Name: duct-to-mucosa Type: Procedure
Name: invagination Type: Procedure
Name: Internal stent Type: Device
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
the Second Affiliated Hospital, School of Medicine, Zhejiang Universtiy
Hangzhou, Zhejiang, China
Status: Recruiting
Contact: Ting-Bo Liang, Ph.D., M.D. - +86 571 87783510 - liangtingbo@zju.edu.cn
Start Date
January 2012
Completion Date
December 2014
TingBo Liang
Zhejiang University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page