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Safety and efficacy of single-port surgical system in choledochal cyst excision and biliary reconstruction in children

Safety and efficacy of single-port surgical system in choledochal cyst excision and biliary reconstruction in children

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080756
Enrollment
Unknown
Registered
2024-02-06
Start date
2024-02-07
Completion date
Unknown
Last updated
2024-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pediatric choledochal cyst

Interventions

Sponsors

Guangzhou Women and Children's Medical Center, Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1) Children with age greater than or equal to 2 years old, weight greater than or equal to 10 kg, and less than or equal to 18 years old, male or female; 2) Patients who were diagnosed as choledochal cyst type I or type IVa according to medical records and imaging examination (B-ultrasound, CT and/or MRI) and planned to undergo radical resection of choledochal cyst; 3) Patients Tolerating CO2 pneumoperitoneum during general anesthesia and robotic surgery; 4) The lesions of common bile duct were not associated with serious complications or malformations of other systems; 5) The guardian of the subjects agreed and signed the informed consent; 6) be willing to cooperate and complete the trial follow-up and related examinations.

Exclusion criteria

Exclusion criteria: 1) patients with severe complications (heart, lung, liver, brain, kidney and other diseases) or weak physique can not tolerate general anesthesia or surgery; 2) patients with severe bleeding tendency or coagulation disorders; 3) patients with active infectious diseases or other severe non-infectious infections; 4) HIV antibody positive; Patients with positive treponema pallidum; 5) patients with previous abdominal surgery history and severe abdominal adhesion; 6) patients need emergency surgical intervention; 7) patients with epilepsy, psychiatric history or cognitive impairment; 8) patients was participating in other interventional clinical research within 3 months before signing the informed consent; 9) other conditions considered by the investigator to be inappropriate for participation in the study.

Design outcomes

Primary

MeasureTime frame
Success rate of operation;

Secondary

MeasureTime frame
Intraoperative bleeding volume;operative time;hospital stay;Postoperative wound pain score;Operator satisfaction;Blood transfusion rate;

Countries

China

Contacts

Public ContactWen zhe

Guangzhou Women and Children's Medical Center, Guangzhou Medical University

wenzhe2005@163.com+86 136 3230 1880

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026