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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Internal stent may be used during pancreaticojejunostomy according to the situation of pancreatic duct and experience of the surgeon.
the Second Affiliated Hospital, School of Medicine, Zhejiang Universtiy
Hangzhou, Zhejiang, China
RECRUITINGpancreatic fistula
The determine of pancreatic fistula follows the International Study Group on Pancreatic Fistulas (ISGPF) criteria.
Time frame: From date of operation until the date of dischage or date of death from any cause, whichever came first,, assessed up to 200 days
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
Time frame: 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
Morbidity
any complications after operation will be recorded.
Time frame: From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days
Reoperation
Reasons and times of reoperation are recorded. The attending doctor will decided Whether reoperation is needed, according to indications and his experience.
Time frame: From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days
Hospital stay
Post-operation hospital stay is assessed.
Time frame: From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days
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