Clinical trial NCT01695447: Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy
Official title: Randomised Controlled Trail of Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy After Pancreaticoduodenectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Neoplasms
Biliary Tract Neoplasms
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2012-09-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: pancreatic fistula
timeFrame: 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 outcomes:
measure: Mortality
timeFrame: 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
measure: Morbidity
timeFrame: From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days
measure: Reoperation
timeFrame: From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days
measure: Hospital stay
timeFrame: From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the Second Affiliated Hospital, School of Medicine, Zhejiang Universtiy
state: Zhejiang
Study officials:
References:
citation: Bai X, Zhang Q, Gao S, Lou J, Li G, Zhang Y, Ma T, Zhang Y, Xu Y, Liang T. Duct-to-Mucosa vs Invagination for Pancreaticojejunostomy after Pancreaticoduodenectomy: A Prospective, Randomized Controlled Trial from a Single Surgeon. J Am Coll Surg. 2016 Jan;222(1):10-8. doi: 10.1016/j.jamcollsurg.2015.10.003. Epub 2015 Oct 21.