Efficacy and Safety of Surgical Treatment for Type IVa CBD

NCT07036848 | Recruiting

• 1 other identifier: 24637-0-01
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multicenter, bidirectional cohort study aimed at continuously enrolling patients with biliary dilatation from 25 medical centers in China. It will collect comprehensive life-cycle data from the cohort to establish a Chinese cohort for IVa biliary dilatation (BD). Based on this cohort, the study seeks to compare the perioperative risks, long-term outcomes, and quality of life of type IVa BD following surgical treatment, to establish standardized surgical treatment strategies for type IVa BD.

Conditions

Choledochal Cyst

Keywords

Biliary Dilatation, Cohort Study, Surgical Treatment

Outcome Measures

Primary Outcomes (1)

• Long-term complication-free survival (LCFS)

  For patients who have undergone surgical treatment, the occurrences of long-term postoperative complications include recurrent cholangitis, intrahepatic bile duct stones, stenosis of the bilioenteric anastomosis, and other such conditions

  After 30 or 90 days of surgery

Secondary Outcomes (5)

• Overall perioperative complication rate

  Within 30 or 90 days postoperatively

• Malignant transformation rate

  Through study completion, an average of 1 year

• Mayo Score

  Through study completion, an average of 6 months

• Severe perioperative complication rate

  Within 30 or 90 days postoperatively

• Reoperation rate

  After 30 or 90 days of surgery

Study Arms (2)

Liver Resection Group

This group included patients with type IVa BD who underwent liver resection, extrahepatic bile duct resection and Roux-en-Y hepaticojejunostomy

Hepaticojejunostomy Group

This group included patients with type IVa BD who underwent extrahepatic bile duct resection and Roux-en-Y hepaticojejunostomy

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with a definitive diagnosis of Todani type IVa biliary dilation in the participating centers

You may qualify if:

• Patients who have been diagnosed with Todani type IVa BD.
• Patients aged between 0 and 80 years old, regardless of gender.
• First-time receipt of surgery.

You may not qualify if:

• With abnormal intrapancreatic bile duct
• Inappropriate Roux-loop length (outside the range of 40-60 cm for adults and 15-30 cm for children)
• With non-relevant surgical interventions
• Pathologically confirmed carcinogenesis
• Unresolved choledocholithiasis, bile duct stenosis, and Intrahepatic bile duct stones during the procedure.
• Unavailable follow-up information.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102218, China

RECRUITING

MeSH Terms

Conditions

Choledochal Cyst

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Shuo Jin, PhD

  Beijing Tsinghua Changgeng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Changzhen Yang, MD

CONTACT

+86 18810915262; ycz23@mail.tsinghua.edu.cn

Shuo Jin, PhD

CONTACT

+86 18611172714; jsa01263@btch.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 25, 2025
• Study Start: July 14, 2025
• Primary Completion: July 14, 2025
• Study Completion (Estimated): July 1, 2035
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)