Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy

TingBo Liang

Status: Unknown

Conditions: Biliary Tract Neoplasms; Pancreatic Neoplasms

Treatments: Procedure: duct-to-mucosa; Procedure: invagination; Device: Internal stent

Study type: Interventional

Funder types: Other

Identifiers

NCT01695447

ZEH-LL-CX-004-02

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

duct-to-mucosa

Experimental group

Description:

duct-to-mucosa technique is used for pancreaticojejunostomy after pancreaticoduodenectomy

Treatment:

Device: Internal stent

Procedure: duct-to-mucosa

invagination

Active Comparator group

Description:

invagination technique is used for pancreaticojejunostomy after pancreaticoduodenectomy

Treatment:

Device: Internal stent

Procedure: invagination