2014-01
2014-12
2015-06
274
NCT01941342
Southwest Hospital, China
Southwest Hospital, China
INTERVENTIONAL
Evaluation of Preoperative Biliary Drainage Before Pancreatoduodenectomy
The purpose of this study is to evaluate the efficacy of preoperative biliary drainage (PBD) which is performed prior to pancreatoduodenectomy candidates with obstructive jaundice by observing the prevalence of drainage and surgery related complications, hospital stay, medical cost and life quality compared to surgery alone. It is anticipated that PBD can reduce the prevalence of complications and improve the outcome of pancreatoduodenectomy.
Obstructive jaundice is a common symptom in patients with pancreatic head cancer or peri-ampullary cancer. It is regarded that proper surgical resection is the only possible way of radical cure for those patients without evidence of metastasis. Since high preoperative bilirubin level is suggested to be a risk factor for pancreatoduodenectomy, preoperative biliary drainage has been applied to clinical practice to improve the outcome of surgery. However, results from previous studies have inconsistent results showing that PBD may have adverse effect on patients by elevating the prevalence of complications. Since PBD is widely performed worldwide, its value needs to be clarified. Thus the present study is designed to systematically evaluate the value of PBD via recruiting participants who may most likely benefit from PBD. It is anticipated that results from this study can present an instructive conclusion on whether PBD should be performed prior to pancreatoduodenectomy as well as reveal the preferable type of PBD.
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 |
|---|---|---|
2013-09-10 | N/A | 2014-01-13 |
2013-09-10 | N/A | 2014-01-14 |
2013-09-13 | N/A | 2014-01 |
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 |
|---|---|
| ACTIVE_COMPARATOR: Pancreatoduodenectomy Instant pancreatoduodenectomy within one week after diagnosis including: Evaluate the resectability; Remove pancreas head, gastric pyloric antrum, duodenum, distal common bile duct and regional lymph nodes; Reconstruct digestive tract. | PROCEDURE: Pancreatoduodenectomy PROCEDURE: ENBD and Pancreatoduodenectomy PROCEDURE: EBD and Pancreatoduodenectomy PROCEDURE: PTCD and Pancreatoduodenectomy |
| EXPERIMENTAL: ENBD and Pancreatoduodenectomy Consistent ENBD (Endoscopic Nasobiliary Drainage) for 3 weeks or drainage until bilirubin level decreases to 200μmol per liter or below then perform pancreatoduodenectomy including: Evaluate the resectability; Remove pancreas head, gastric pyloric antrum | PROCEDURE: ENBD and Pancreatoduodenectomy |
| EXPERIMENTAL: EBD and Pancreatoduodenectomy Consistent EBD (Endoscopic Biliary Drainage) for 3 weeks or drainage until bilirubin level decreases to 200μmol per liter or below then perform pancreatoduodenectomy including: Evaluate the resectability; Remove pancreas head, gastric pyloric antrum, duo | PROCEDURE: EBD and Pancreatoduodenectomy |
| EXPERIMENTAL: PTCD and Pancreatoduodenectomy Consistent PTCD (Percutaneous Transhepatic Cholangial Drainage) for 3 weeks or drainage until bilirubin level decreases to 200μmol per liter or below then perform pancreatoduodenectomy including: Evaluate the resectability; Remove pancreas head, gastric | PROCEDURE: PTCD and Pancreatoduodenectomy |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Incidence of Infectious Complications | up to 12 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Incidence of Hemorrhagic Complications | up to 6 months | |
| Liver Function Evaluation | up to 6 months | |
| Incidence of Bile Leakage | up to 6 months | |
| Incidence of Pancreatic Leakage | up to 6 months | |
| Life Quality Score | up to 12 months | |
| Digestive Function Recovery | up to 6 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Huai-zhi Wang, M.D., Ph.D. Phone Number: 86-23-13996950719 Email: whuaizhi@gmail.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
No publications available
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