NCT07800169

Brief Summary

This retrospective study aims to systematically analyze the factors influencing short-term rehabilitation and liver function recovery after radical surgery for pediatric common bile duct cysts, identify independent risk factors, construct a risk prediction model, and provide an evidence-based basis for optimizing perioperative management.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 2, 2026

Completed
Last Updated

September 2, 2026

Status Verified

August 1, 2026

Enrollment Period

7 months

First QC Date

August 20, 2026

Last Update Submit

August 29, 2026

Conditions

Keywords

choledochal cystpostoperative flatusRoux-en-Y hepaticojejunostomypediatric surgery

Outcome Measures

Primary Outcomes (3)

  • First flatus time (hours)

    From the date of surgery until the date of first flatus, assessed up to 7 days postoperatively.

  • First defecation time

    From the date of surgery until the date of first defecation, assessed up to 7 days postoperatively.

  • Postoperative length of hospital stay (days)

    From the date of surgery until the date of hospital discharge, assessed up to 3 months postoperatively.

Eligibility Criteria

Age1 Week - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

This study enrolled patients admitted between 2017 and 2025 to the Department of Hepatobiliary Surgery at Wuhan Children's Hospital, Anhui Provincial Children's Hospital, Shanxi Provincial Children's Hospital, Tianjin Children's Hospital, or the Affiliated Hospital of Zunyi Medical University. All patients were scheduled to receive either laparoscopic cholecystectomy and choledochal cyst excision, end-to-side jejunojejunal Y anastomosis and hepaticojejunostomy, or robot-assisted laparoscopic cholecystectomy and choledochal cyst excision, end-to-side jejunojejunal Y anastomosis and hepaticojejunostomy. The target population was patients aged 0-16 years who were definitively diagnosed with choledochal cyst via preoperative pathology or imaging examination, and met the indications for elective surgery. All enrolled patients must have complete perioperative clinical data, and be able to cooperate with postoperative follow-up observation until discharge.

You may qualify if:

  • \) Age between 0-16 years, meeting the age-based classification criteria for pediatric patients; 2) Diagnosis of common bile duct cyst confirmed by imaging studies (liver and gallbladder ultrasonography, MRCP, or CT), with histological typing performed according to the Todani classification system; 3) First-time surgical resection of the common bile duct cyst combined with radical Roux-en-Y hepatojejunal anastomosis; 4) Complete clinical medical records, preoperative laboratory test data, intraoperative surgical documentation, postoperative rehabilitation and follow-up data; 5) The study cases are affiliated with respective participating research centers, and inpatient and follow-up data can be readily retrieved.

You may not qualify if:

  • \) Children with severe end-stage liver cirrhosis, irreversible liver failure, or malignant biliary tract tumors; 2) Children with severe multi-organ failure (e.g., cardiac, pulmonary, or renal failure) who cannot be adequately assessed for surgical prognosis; 3) Children undergoing secondary surgery or those with recurrent choledochal cysts; 4) Children who have only undergone palliative stoma creation or percutaneous drainage without receiving radical surgical intervention; 5) Cases in which critical perioperative clinical data are missing, making it impossible to meet the requirements for data analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan Children'c Hospital

Wuhan, Hubei, 430016, China

Location

MeSH Terms

Conditions

Choledochal Cyst

Condition Hierarchy (Ancestors)

CystsNeoplasmsBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesDigestive System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Xueqiang Yan, Doctor

    Wuhan Children's Hospital

    STUDY CHAIR
  • Liang Ge

    Tianjin Children's Hospital

    PRINCIPAL INVESTIGATOR
  • Chen Yu

    Anhui Provincial Children's Hospital

    PRINCIPAL INVESTIGATOR
  • Zhu Jin

    Zunyi Medical College

    PRINCIPAL INVESTIGATOR
  • Xiaoxia Wu

    Shanxi Provincial Maternity and Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 20, 2026

First Posted

September 2, 2026

Study Start

January 1, 2026

Primary Completion

July 31, 2026

Study Completion

July 31, 2026

Last Updated

September 2, 2026

Record last verified: 2026-08

Locations