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A single arm multicenter clinical study on the effectiveness and safety of radical surgery for pediatric Choledochal Cyst based on the Da Vinci Xi system Single-port Technology

A single arm multicenter clinical study on the effectiveness and safety of radical surgery for pediatric Choledochal Cyst based on the Da Vinci Xi system Single-port Technology

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104980
Enrollment
Unknown
Registered
2025-06-26
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-06-30

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

Conditions

Choledochal Cyst

Interventions

Experimental group:Radical resection of choledochal cyst using single-port platform based on Da Vinci Xi system

Sponsors

Fuzhou University Affiliated Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 14 Years

Inclusion criteria

Inclusion criteria: 1. Age and diagnosis: 0-14 years old, confirmed by ultrasound, MRI/MRCP or intraoperative cholangiogram with Todani type I or type IV choledochal cyst (subtype requiring surgical intervention); 2. Indications for surgery: no acute infection (such as no fever, normal C-reactive protein); 3. Anatomical conditions: no severe abdominal adhesions (preoperative imaging evaluation), clear and distinguishable anatomical structure of the hilar part of the liver; 4. Family cooperation: The guardian agrees to perform robotic surgery, signs the informed consent form, and promises to cooperate with the postoperative follow-up.

Exclusion criteria

Exclusion criteria: 1. Contraindications for comorbidities: severe cardiopulmonary insufficiency, coagulation dysfunction (INR>1.5 or platelets <80×10^9/L) or other contraindications to robotic surgery; 2. Complex pathological state: history of previous epigastric surgery, combined with intrahepatic bile duct dilation requiring combined hepatic lobectomy, suspected cancerous transformation (imaging showed cyst wall thickening with enhancement); 3. Technical limitations: special location of the cyst or severe anatomical variation (such as close to the main trunk of the portal vein, and it is difficult to safely separate the single-port viewing angle); 4. Ethical exclusion: not approved by the hospital ethics committee or refusal of the guardian to participate in the study.

Design outcomes

Primary

MeasureTime frame
Surgical success rate;Intraoperative bleeding volume;Operative time;Postoperative hospitalization days;Long term prognosis;

Secondary

MeasureTime frame
Incidence of postoperative complications;Wound beauty rating;

Countries

China

Contacts

Public ContactXu Di

Fuzhou University Affiliated Provincial Hospital

doc_xudi@163.com+86 138 0509 8051

Outcome results

None listed

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