Biliary Tract Neoplasms, Pancreatic Neoplasms
Conditions
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.
Interventions
PROCEDUREduct-to-mucosa
PROCEDUREinvagination
DEVICEInternal stent
Internal stent may be used during pancreaticojejunostomy according to the situation of pancreatic duct and experience of the surgeon.
Sponsors
TingBo Liang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactXue-Li Bai, Ph.D.
Outcome results
None listed