Individualized Drainage Strategy Based on Risk Stratification in Children Undergoing Surgery for Choledochal Cyst: A Prospective Randomized Controlled Trial

NCT07825935 | Not Yet Recruiting DMC

• 2 other identifiers: 2026R085-F012025FEYJS005
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Choledochal cyst is a common congenital biliary malformation in children requiring cyst excision with Roux-en-Y hepaticojejunostomy. Traditional practice routinely places abdominal drainage tubes postoperatively. With the improved precision of robot-assisted surgery, the necessity of routine drainage has been questioned. This prospective randomized controlled trial aims to evaluate whether a selective drainage strategy based on a preoperative predictive model (using cyst diameter, age, BMI, hemoglobin, and globulin) is safe and effective compared with conventional routine drainage in children undergoing robot-assisted Roux-en-Y hepaticojejunostomy. The primary outcome is the incidence of Clavien-Dindo grade ≥III complications within 30 days postoperatively.

Conditions

Choledochal Cyst; Children Following Robot-assisted Roux-en-Y Hepaticojejunostomy for Choledochal Cysts

Outcome Measures

Primary Outcomes (2)

• Incidence of Severe Complications Within 30 Days Postoperatively

  Incidence of Clavien-Dindo grade ≥III complications within 30 days after robot-assisted Roux-en-Y hepaticojejunostomy, including bile leakage, pancreatic leakage, intra-abdominal hemorrhage, intra-abdominal infection, wound infection, anastomotic stenosis, reoperation, and mortality.

  30 days after surgery

• Incidence of Severe Complications Within 90 Days Postoperatively

  Incidence of Clavien-Dindo grade ≥III complications within 90 days after robot-assisted Roux-en-Y hepaticojejunostomy.

  Postoperative 90 days

Study Arms (2)

Selective Drainage Group

EXPERIMENTAL

Patients with low-risk prediction (\<85%) do not receive abdominal drainage; patients with high-risk prediction (≥85%) receive drainage tube placement.

Procedure: Robot-Assisted Roux-en-Y Hepaticojejunostomy with Drainage Management

Conventional Drainage Group

ACTIVE COMPARATOR

All patients receive routine abdominal drainage tube placement postoperatively.

Procedure: Robot-Assisted Roux-en-Y Hepaticojejunostomy with Drainage Management

Interventions

Robot-Assisted Roux-en-Y Hepaticojejunostomy with Drainage Management PROCEDURE

All enrolled children undergo Da Vinci robot-assisted Roux-en-Y hepaticojejunostomy. The intervention differentiates in postoperative drainage management: the Selective Drainage Group receives abdominal drainage only when preoperative risk probability is ≥85%, while the Conventional Drainage Group receives routine drainage for all patients.

Conventional Drainage Group; Selective Drainage Group

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• Xueqiang Yan: lead

Study Sites (1)

Wuhan Children'c Hospital

Wuhan, Hubei, 430016, China

Location

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

Central Study Contacts

Xueqiang Yan, Doctor

CONTACT

+8615871716704; yanxueqiang1@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Arm 1: Experimental Group (Selective Drainage Group) Arm Title (Group Name): Selective Peritoneal Drainage Group or Experimental: Selective Drainage Group Arm Type (Group Type): Typically selected as Experimental (Experimental) Description (Description): Based on preoperative predictive models (cyst diameter, BMI, HGB, GLB, etc.), risk probability is calculated, and abdominal drainage tubes are placed only in high-risk children, while low-risk children do not receive drainage tubes. Arm 2: Control Group (Conventional Drainage Group) Arm Title: Conventional Peritoneal Drainage Group or Active Comparator: Conventional Drainage Group Arm Type: Select Active Comparator (Active Control) or No Intervention (No Intervention? But here there is conventional drainage, so Active Comparator should be selected) Description: All children receive conventional abdominal drainage tubes postoperatively.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 5, 2026
• First Posted: September 17, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)