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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| duct-to-mucosa | Experimental | duct-to-mucosa technique is used for pancreaticojejunostomy after pancreaticoduodenectomy |
|
| invagination | Active Comparator | invagination technique is used for pancreaticojejunostomy after pancreaticoduodenectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| duct-to-mucosa | Procedure |
| ||
| invagination |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xue-Li Bai, Ph.D. | Contact | +86 571 87783510 | shirleybai57@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Second Affiliated Hospital, School of Medicine, Zhejiang Universtiy | Recruiting | Hangzhou | Zhejiang | 310009 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26577499 | Derived | 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. |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D001661 | Biliary Tract Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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|
| Internal stent | Device | Internal stent may be used during pancreaticojejunostomy according to the situation of pancreatic duct and experience of the surgeon. |
|
| 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 |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001660 | Biliary Tract Diseases |