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2016-09
2018-11
2018-12
140
NCT02954302
The First Affiliated Hospital of Xiamen University
The First Affiliated Hospital of Xiamen University
INTERVENTIONAL
Proximal Roux-en-y Gastrojejunal Anastomosis on Delayed Gastric Emptying After Pylorus-resecting Pancreaticoduodenectomy
This study aims to evaluate whether the incidence of delayed gastric emptying (DGE) can be reduced by proximal Roux-en-y gastrojejunal anastomosis in comparison with the standard gastrojejunal anastomosis in pylorus-resecting pancreaticoduodenectomy (PrPD).
Delayed gastric emptying (DGE) is a common complication after pancreaticoduodenectomy (PD), occurring in 20% to 70% of the patients. DGE is usually not a life-threatening complication, but it contributes significantly to increased length of hospital stay, health care costs, and patient discomfort. In a recent study by Sakamoto et al, proximal Roux-en-y gastrojejunal anastomosis is associated with a reduced incidence of DGE after pylorus-resecting pancreaticoduodenectomy (PrPD); however, these results may have been biased because of the retrospective nature. Therefore, the investigators conducted the present randomized controlled trial (RCT) to evaluate the impact of the proximal Roux-en-y gastrojejunal anastomosis on reducing DGE following PrPD.
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 |
|---|---|---|
2016-09-07 | N/A | 2016-11-01 |
2016-11-01 | N/A | 2016-11-03 |
2016-11-03 | N/A | 2016-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Prevention
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: PrPD with RGA Patients who will undergo PrPD with proximal Roux-en-y gastrojejunal anastomosis. | PROCEDURE: PrPD with proximal Roux-en-y gastrojejunal anastomosis
|
| EXPERIMENTAL: conventional PrPD Patients who will undergo conventional PrPD. | PROCEDURE: conventional PrPD
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Delayed gastric emptying,rate | The severity of DGE was classified into 3 grades (A, B, or C) according to the ISGPS's clinical criteria, based on the patient's clinical course and postoperative management, such as the need for NGT in the postoperative period or the inability to tolerate solid oral intake. Grade A was defined as needing the NGT for more than 7 days or reinsertion of the NGT after postoperative day 3, or as being unable to tolerate a solid diet by postoperative day 7. Grade B was defined as needing for NGT for 8 to 14 days after surgery or reinsertion of the NGT after day 7, or as being unable to tolerate a solid diet by postoperative day 14. Grade C was defined as needing the NGT for more than 14 days or reinsertion of the NGT after day 14, or as being unable to tolerate a solid diet by day 21. | 60 days after operation |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Morbidity,rate | 60 days after operation | |
| Mortality,rate | 60 days after operation | |
| Length of hospital stay,days | 60 days after operation | |
| Pancreatic fistula,rate | 60 days after operation | |
| Hemorrhage,rate | 60 days after operation | |
| Bile leakage,rate | 60 days after operation | |
| Intra-abdominal abscess,rate | 60 days after operation | |
| wound infection,rate | 60 days after operation |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Mingqiang Lin, Dr Phone Number: 8605922139708 Email: 80218353@qq.com |
Study Contact Backup Name: Yanming Zhou, Dr Phone Number: 8605922139708 Email: zhouymsxy@sina.cn |
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
