2012-01
2017-12
2017-12
100
NCT01695447
Zhejiang University
Zhejiang University
INTERVENTIONAL
Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2012-09-20 | N/A | 2017-01-25 |
2012-09-27 | N/A | 2017-01-26 |
2012-09-28 | N/A | 2017-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Triple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: duct-to-mucosa duct-to-mucosa technique is used for pancreaticojejunostomy after pancreaticoduodenectomy | PROCEDURE: duct-to-mucosa DEVICE: Internal stent
|
| ACTIVE_COMPARATOR: invagination invagination technique is used for pancreaticojejunostomy after pancreaticoduodenectomy | PROCEDURE: invagination DEVICE: Internal stent
|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Xue-Li Bai, Ph.D. Phone Number: +86 571 87783510 Email: shirleybai57@hotmail.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
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