NCT06541340 A New Strategy for Preoperative Drainage of Resectable Pancreatic Head Cancer Combined Severe Obstructive Jaundice
| NCT ID | NCT06541340 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ruijin Hospital |
| Condition | Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 360 participants in total. It began in 2024-08-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. 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 2. Preoperative imaging stage is resectable 3. Baseline serum total bilirubin ≥ 250μmol/L, and no history of preoperative biliary drainage 4. Age \>18 and ≤75 years old 5. ECOG(Eastern Cooperative Oncology Group) physical score ≤ 2 6. Signed informed consent, received preoperative endoscopic biliary drainage (ERCP) and radical surgery timing evaluation Exclusion Criteria: 1. Combined with other malignant tumors 2. Combined with uncontrolled medical diseases or organ dysfunction and other absolute counterindications for surgery 3. Pregnant and lactating women 4. Patients who cannot tolerate preoperative biliary drainage or radical surgery 5. Other situations that are not suitable for inclusion in clinical trials
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06541340 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06541340 currently recruiting?
Yes, NCT06541340 is actively recruiting participants. Contact the research team at zj11477@rjh.com.cn for enrollment information.
Where is the NCT06541340 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06541340 clinical trial?
NCT06541340 is sponsored by Ruijin Hospital. The trial plans to enroll 360 participants.
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