Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy

Pancreatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01695447
• Other study ID #: ZEH-LL-CX-004-02
• Status: Recruiting
• Phase: N/A
• First received: September 20, 2012
• Last updated: January 25, 2017
• Start date: January 2012
• Est. completion date: December 2017

Study information

• Verified date: January 2017
• Source: Zhejiang University
• Contact: Xue-Li Bai, Ph.D.
• Phone: +86 571 87783510
• Email: shirleybai57[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Biliary Tract Neoplasms
• Neoplasms
• Pancreatic Neoplasms

Intervention

Procedure:
• duct-to-mucosa

• invagination

Device:
• Internal stent
Internal stent may be used during pancreaticojejunostomy according to the situation of pancreatic duct and experience of the surgeon.

Locations

Country	Name	City	State
China	the Second Affiliated Hospital, School of Medicine, Zhejiang Universtiy	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
TingBo Liang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pancreatic fistula	The determine of pancreatic fistula follows the International Study Group on Pancreatic Fistulas (ISGPF) criteria.	From date of operation until the date of dischage or date of death from any cause, whichever came first,, assessed up to 200 days
Secondary	Mortality	30-day or in-hospital mortality: death from any cause within 30 days after operation or any in-hospital death are considered concerned with the type of pancreaticojejunostomy	From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days
Secondary	Morbidity	any complications after operation will be recorded.	From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days
Secondary	Reoperation	Reasons and times of reoperation are recorded. The attending doctor will decided Whether reoperation is needed, according to indications and his experience.	From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days
Secondary	Hospital stay	Post-operation hospital stay is assessed.	From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days