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

NCT06541340 | Recruiting

• 1 other identifier: PROB
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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

Keywords

pancreatic head cancer; obstructive Jaundice; preoperative biliary drainage; prealbumin

Outcome Measures

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.

  During hospitalization, up tp 3 months

Secondary Outcomes (3)

• Recurrence/metastasis

  12 months after discharge

• Mortality

  12 months after discharge

• Long-term complications

  12 months after discharge

Study Arms (2)

Traditional strategy

ACTIVE COMPARATOR

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

Procedure: Traditional strategy

Modified strategy

EXPERIMENTAL

Modified preoperative biliary drainage strategy with prealbumin as the main indicator

Procedure: Modified strategy

Interventions

Modified strategy PROCEDURE

Modified preoperative biliary drainage strategy with prealbumin as the main indicator

Modified strategy

Traditional strategy PROCEDURE

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

Traditional strategy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ECOG(Eastern Cooperative Oncology Group) physical score ≤ 2
• Signed informed consent, received preoperative endoscopic biliary drainage (ERCP) and radical surgery timing evaluation

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Jaundice, Obstructive

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Jaundice; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Central Study Contacts

Jun Zhang, Ph.D&M.D

CONTACT

+86 18917530547; zj11477@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 7, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 7, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)