A New Strategy for Preoperative Drainage of Resectable Pancreatic Head Cancer Combined Severe Obstructive Jaundice
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRuijin Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pathological diagnosis of pancreatic head cancer, or clinical diagnosis of pancreatic head cancer after multidisciplinary discussion, clear presence of obstructive jaundice caused by pancreatic head tumor, and planned to undergo radical pancreaticoduodenectomy
Preoperative imaging stage is resectable
Baseline serum total bilirubin ≥ 250μmol/L, and no history of preoperative biliary drainage
Age >18 and ≤75 years old
Disqualifiers
Combined with other malignant tumors
Combined with uncontrolled medical diseases or organ dysfunction and other absolute counterindications for surgery
Pregnant and lactating women
Patients who cannot tolerate preoperative biliary drainage or radical surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Modified strategy
Procedure/SurgeryModified preoperative biliary drainage strategy with prealbumin as the main indicator
Traditional strategy
Procedure/SurgeryTraditional preoperative biliary drainage strategy with total bilirubin as the main indicator
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: Traditional strategyActive comparator 1 intervention
Group B: Modified strategyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
During hospitalization, up tp 3 monthsSecondary outcomes
1
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.
Time frame
12 months after discharge2
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.
Time frame
12 months after discharge3
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.
Time frame
12 months after dischargeSponsors and contacts
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Source ClinicalTrials.gov