Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy

Study Overview
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Brief Summary
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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.

Official Title
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Randomised Controlled Trail of Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy After Pancreaticoduodenectomy

Conditions
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Pancreatic Neoplasms, Biliary Tract Neoplasms

Intervention / Treatment
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* Procedure: duct-to-mucosa
* Procedure: invagination
* Device: Internal stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: duct-to-mucosa<br>duct-to-mucosa technique is used for pancreaticojejunostomy after pancreaticoduodenectomy | Procedure: duct-to-mucosa<br> <br> Device: Internal stent<br>* Internal stent may be used during pancreaticojejunostomy according to the situation of pancreatic duct and experience of the surgeon.<br>|
| Active Comparator: invagination<br>invagination technique is used for pancreaticojejunostomy after pancreaticoduodenectomy | Procedure: invagination<br> <br> Device: Internal stent<br>* Internal stent may be used during pancreaticojejunostomy according to the situation of pancreatic duct and experience of the surgeon.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pancreatic fistula | The determine of pancreatic fistula follows the International Study Group on Pancreatic Fistulas (ISGPF) criteria. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | 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. | From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days |