NCT05620485

Brief Summary

In this prospective study, we tried to select the operation time according to the cyst size and evaluate the treatment effect.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Nov 2022

Longer than P75 for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Nov 2022Nov 2026

First Submitted

Initial submission to the registry

October 2, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

November 15, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2026

Expected
Last Updated

November 17, 2022

Status Verified

November 1, 2022

Enrollment Period

3 years

First QC Date

October 2, 2022

Last Update Submit

November 12, 2022

Conditions

Choledochal Cyst

Outcome Measures

Primary Outcomes (22)

  • preoperative complications

    number of participants progressed to CDC-related symptoms before operative intervention

    pre-intervention

  • preoperative complications

    number of participants with cyst rupture before operative intervention

    pre-intervention

  • preoperative complications

    aspartate aminotransferase (U/L)

    1 week before surgery

  • preoperative complications

    alanine aminotransferase (U/L)

    1 week before surgery

  • preoperative complications

    γ-glutamyl transpeptidase (U/L)

    1 week before surgery

  • preoperative complications

    Serum Bilirubin (μmol/L）

    1 week before surgery

  • short-term complications

    number of participants with post-operative anastomotic leak

    1 weak after surgery

  • short-term complications

    number of participants with postoperative hemorrhage

    1 weak after surgery

  • short-term complications

    aspartate aminotransferase (U/L)

    1 weak after surgery

  • short-term complications

    alanine aminotransferase (U/L)

    1 weak after surgery

  • short-term complications

    γ-glutamyl transpeptidase (U/L)

    1 weak after surgery

  • short-term complications

    Serum Bilirubin (μmol/L）

    1 weak after surgery

  • short-term complications

    aspartate aminotransferase (U/L)

    3 months after surgery

  • short-term complications

    alanine aminotransferase (U/L)

    3 months after surgery

  • short-term complications

    γ-glutamyl transpeptidase (U/L)

    3 months after surgery

  • short-term complications

    Serum Bilirubin (μmol/L）

    3 months after surgery

  • short-term complications

    aspartate aminotransferase (U/L)

    6 months after surgery

  • short-term complications

    alanine aminotransferase (U/L)

    6 months after surgery

  • short-term complications

    γ-glutamyl transpeptidase (U/L)

    6 months after surgery

  • short-term complications

    Serum Bilirubin (μmol/L）

    6 months after surgery

  • short-term complications

    number of participants with postoperative wound infection

    1 month after surgery

  • Long-term complications

    number of participants with anastomotic stricture

    3 years after surgery

Secondary Outcomes (3)

  • length of stay

    1 month after surgery

  • duration of ventilator support

    1 month after surgery

  • length of nutritional support in hospital

    1 month after surgery

Study Arms (1)

prenatally diagnosed CDC

EXPERIMENTAL

All patients received laparoscopic-assisted CDC excision and hepaticojejunostomy.

Procedure: laparoscopic-assisted CDC excision and hepaticojejunostomy

Interventions

laparoscopic-assisted CDC excision and hepaticojejunostomyPROCEDURE

After birth, the liver and gallbladder ultrasound were regularly rechecked. If the maximum diameter of the cyst was greater than 5 cm, surgery was performed.

prenatally diagnosed CDC

Eligibility Criteria

Age0 Months - 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants with a prenatal and postnatal diagnosis with CDC
  • Prenatal and postnatal hepatobiliary ultrasound data were complete
  • Age of visit \< 3 months

You may not qualify if:

  • Unable to tolerate surgery after birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Choledochal Cyst

Condition Hierarchy (Ancestors)

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

Central Study Contacts

xisi guan

CONTACT

13926155230545280987@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical attending doctor

Study Record Dates

First Submitted

October 2, 2022

First Posted

November 17, 2022

Study Start

November 15, 2022

Primary Completion

November 15, 2025

Study Completion (Estimated)

November 15, 2026

Last Updated

November 17, 2022

Record last verified: 2022-11