A New Strategy for Preoperative Drainage of Resectable Pancreatic Head Cancer Combined Severe Obstructive Jaundice

NCT ID: NCT06541340

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2026-12-31

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.

Conditions

Pancreatic Cancer; Obstructive Jaundice

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Traditional strategy

Traditional preoperative biliary drainage strategy with total bilirubin as the main indicator

Group Type: ACTIVE_COMPARATOR

Traditional strategy

Intervention Type: PROCEDURE

Traditional preoperative biliary drainage strategy with total bilirubin as the main indicator

Modified strategy

Modified preoperative biliary drainage strategy with prealbumin as the main indicator

Group Type: EXPERIMENTAL

Modified strategy

Intervention Type: PROCEDURE

Modified preoperative biliary drainage strategy with prealbumin as the main indicator

Interventions

Modified strategy

Modified preoperative biliary drainage strategy with prealbumin as the main indicator

Intervention Type: PROCEDURE

Traditional strategy

Traditional preoperative biliary drainage strategy with total bilirubin as the main indicator

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jun Zhang, Ph.D&M.D

Role: CONTACT

zj11477@rjh.com.cn

+86 18917530547

Facility Contacts

Baiyong Shen, Ph.D&M.D

Role: primary

0086-021-64370045

Other Identifiers

PROB

Identifier Type: -

Identifier Source: org_study_id