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2024-08-01
2026-12-31
2026-12-31
360
NCT06541340
Ruijin Hospital
Ruijin Hospital
INTERVENTIONAL
A New Strategy for Preoperative Drainage of Resectable Pancreatic Head Cancer Combined Severe Obstructive Jaundice
Severe obstructive jaundice caused by pancreatic head cancer usually requires preoperative biliary drainage, but its necessity and effectiveness are controversial, and specific strategies lack clear standards. This study proposed a new strategy for preoperative biliary drainage using serum prealbumin as the main evaluation index, and compared it with the traditional strategy using serum total bilirubin as the main evaluation index. Through a randomized, controlled, multicenter prospective study, we explored the effects of different drainage strategies on the incidence of in-hospital complications and long-term prognosis of patients with resectable pancreatic head cancer, guided clinical decisions on preoperative drainage time and surgical timing, and provided high-quality evidence-based medicine for preoperative biliary drainage of pancreatic head cancer.
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 |
|---|---|---|
2024-07-30 | N/A | 2024-08-06 |
2024-08-06 | N/A | 2024-08-07 |
2024-08-07 | N/A | 2024-07 |
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:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: Traditional strategy Traditional preoperative biliary drainage strategy with total bilirubin as the main indicator | PROCEDURE: Traditional strategy
|
| EXPERIMENTAL: Modified strategy Modified preoperative biliary drainage strategy with prealbumin as the main indicator | PROCEDURE: Modified strategy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| In-hospital complications | In-hospital complications are comprehensively evaluated by the chief surgeon, responsible doctor and their team based on clinical manifestations, laboratory tests, etc., and reviewed by the expert committee of this study. The name of the complication, time of occurrence, treatment measures and outcome are strictly recorded. | During hospitalization, up tp 3 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Recurrence/metastasis | It is mainly based on follow-up. If the follow-up was completed in our hospital, the hospital system will be directly retrieved to obtain the diagnosis information. The follow-up was conducted by interviewing the patient or his family members through telephone questionnaires or face-to-face visits to collect required information.The follow-up subjects provide medical records, etc., and record in detail the time of diagnosis of long-term complications or recurrence and metastasis, diagnostic basis, laboratory tests, treatment measures and outcomes, which must be reviewed by the expert committee of this study. | 12 months after discharge |
| Mortality | It is mainly based on follow-up. If the follow-up was completed in our hospital, the hospital system will be directly retrieved to obtain the diagnosis information. The follow-up was conducted by interviewing the patient or his family members through telephone questionnaires or face-to-face visits to collect required information.The follow-up subjects provide medical records, etc., and record in detail the time of diagnosis of long-term complications or recurrence and metastasis, diagnostic basis, laboratory tests, treatment measures and outcomes, which must be reviewed by the expert committee of this study. | 12 months after discharge |
| Long-term complications | It is mainly based on follow-up. If the follow-up was completed in our hospital, the hospital system will be directly retrieved to obtain the diagnosis information. The follow-up was conducted by interviewing the patient or his family members through telephone questionnaires or face-to-face visits to collect required information.The follow-up subjects provide medical records, etc., and record in detail the time of diagnosis of long-term complications or recurrence and metastasis, diagnostic basis, laboratory tests, treatment measures and outcomes, which must be reviewed by the expert committee of this study. | 12 months after discharge |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Jun Zhang, Ph.D&M.D Phone Number: +86 18917530547 Email: zj11477@rjh.com.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
No publications available
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