Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy

Not Applicable

• Conditions: Biliary Tract Neoplasms; Pancreatic Neoplasms
• Interventions: Procedure: invagination; Procedure: duct-to-mucosa; Device: Internal stent

• Registration Number: NCT01695447
• Lead Sponsor: TingBo Liang

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-09-20
• Study First Submitted QC: 2012-09-27
• Study First Posted: 2012-09-28
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-25
• Last Update Posted: 2017-01-26
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
invagination	invagination	invagination technique is used for pancreaticojejunostomy after pancreaticoduodenectomy
duct-to-mucosa	duct-to-mucosa	duct-to-mucosa technique is used for pancreaticojejunostomy after pancreaticoduodenectomy
duct-to-mucosa	Internal stent	duct-to-mucosa technique is used for pancreaticojejunostomy after pancreaticoduodenectomy
invagination	Internal stent	invagination technique is used for pancreaticojejunostomy after pancreaticoduodenectomy

Primary Outcome Measures

Name	Time	Method
pancreatic fistula	From date of operation until the date of dischage or date of death from any cause, whichever came first,, assessed up to 200 days	The determine of pancreatic fistula follows the International Study Group on Pancreatic Fistulas (ISGPF) criteria.

Secondary Outcome Measures

Name	Time	Method
Mortality	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	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
Morbidity	From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days	any complications after operation will be recorded.
Reoperation	From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days	Reasons and times of reoperation are recorded. The attending doctor will decided Whether reoperation is needed, according to indications and his experience.
Hospital stay	From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days	Post-operation hospital stay is assessed.

Trial Locations

Locations (1)

the Second Affiliated Hospital, School of Medicine, Zhejiang Universtiy; 🇨🇳 Hangzhou, Zhejiang, China