ERAS in Choledochal Cyst & Biliary Atresia

NCT07709702 | Recruiting

• 1 other identifier: 1139/CH-UCHS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare two feeding approaches after surgery for biliary atresia and choledochal cyst in children. Traditionally, children are kept without oral feeding for more than 48 hours after these operations until bowel activity returns. However, newer Enhanced Recovery After Surgery (ERAS) programs suggest that starting feeding earlier may help children recover faster. In this study, children undergoing surgery for biliary atresia or choledochal cyst will be randomly assigned to one of two groups. One group will start oral liquids within 24 hours after surgery and gradually progress to normal feeding as tolerated (early feeding group). The other group will receive conventional care, where feeding is started after more than 48 hours once bowel activity has returned. Researchers will compare both groups for postoperative complications such as wound infection and anastomotic leakage, as well as the duration of hospital stay. Additional observations will include vomiting, abdominal distension, need for reinsertion of a nasogastric tube, requirement for repeat surgery, and time taken to resume normal feeding. Participation in the study will not affect the standard surgical treatment provided. All children will receive routine perioperative care and will be monitored closely throughout their hospital stay and follow-up visits. The findings of this study may help determine whether early oral feeding is a safe and effective strategy to improve recovery and reduce hospitalization after pediatric hepatobiliary surgery.

Conditions

Choledochal Cyst Resection; Biliary Atresia, Kasai Portoenterostomy Status

Keywords

ERAS; Choledochal Cyst; Pediatric; Children; Post-Operative Management; Biliary Atresia; Feeding Protocol; Fast-Tract Discharge; Hospital Stay

Outcome Measures

Primary Outcomes (3)

• Wound Infection

  Condition characterized with presence of redness, swelling, warmth, pain or purulent discharge from surgical site classified according to CDC SSI grading.

  Within 04 weeks of surgery

• Anastomotic Leak

  When surgical anastomosis fails and there is leakage proven with signs of peritonitis on clinical examination, pneumoperitoneum on radiographs

  Within hospital stay or on readmission within 1 month

• Length of Hospital Stay

  Duration of stay measured in days

  From the date of surgery until the date of hospital discharge, assessed up to 30 days

Secondary Outcomes (3)

• Vomiting

  From start of feeding till 30 days post-operatively

• Abdominal Distension

  from initiation of oral feeds till 30 days post-operatively

• Need for Re-operation

  From start of oral feeds till 04 weeks post-op

Study Arms (4)

ERAS Feeding Protocol in Choledochal Cyst

EXPERIMENTAL

The patients with Roux-en-Y hepaticojejunostomy for choledochal cyst will be started oral liquids within 24 hours of surgery, NG Tube will be removed before starting oral feeds

Other: Enhanced Recovery After Surgery

Conventional Feeding Protocol in Choledochal Cyst

ACTIVE COMPARATOR

The post operative patients of Roux-en-Y hepaticojejunostomy for choledochal cyst will be allowed oral liquids after confirmation of resumption of bowel function (Positive bowel sounds, passage of stool or flatus, clear NG aspirate)

Other: Post-operative care

ERAS in Biliary Atresia

EXPERIMENTAL

Post-op patients of Roux-en-Y portoenterostomy for biliary atresia will be allowed oral liquids within 24 hours of surgery and NG tube will be removed.

Other: Enhanced Recovery After Surgery

Conventional feeding protocol in Biliary Atresia

ACTIVE COMPARATOR

Post-op patients of portoenterostomy for biliary atresia will be allowed oral feeds only after confirmation of bowel functions (positive bowel sounds, passage of stool or flatus, clearing of NG aspirate)

Other: Post-operative care

Interventions

Enhanced Recovery After Surgery OTHER

In ERAS feeding protocol or early oral feeding protocol, patients will be allowed oral liquids within 24 hours of surgery irrespective of confirmation of bowel functions.

Also known as: Fast-tract feeding protocol, Early oral feeding

ERAS Feeding Protocol in Choledochal Cyst; ERAS in Biliary Atresia

Post-operative care OTHER

In conventional feeding protocol, feeds will be resumed after surgery on confirmation of bowel functions with auscultation for bowel sounds or passage of stool or flatus, usually after 48 hours

Also known as: Conventional Feeding Protocol

Conventional Feeding Protocol in Choledochal Cyst; Conventional feeding protocol in Biliary Atresia

Eligibility Criteria

• Age: 1 Month - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All children diagnosed with choledochal cyst type I and IV on MRCP or CT scan, undergoing elective Roux-En-Y hepaticojejunostomy
• All children with provisional diagnosis of biliary atresia undergoing Roux-En-Y portoenterostomy

You may not qualify if:

• Patients with suspected biliary atresia not undergoing portoenterostomy after Per-op cholangiogram either due to ruling out of disease or advanced disease deemed candidates for liver transplant
• patients with history of Emergency surgery or external drainage of choledochal cyst
• Hemodynamically unstable patients after surgery
• Previous history of GI surgery

Sponsors & Collaborators

• Muhammad Zubair Shoukat: lead
• University of Child Health Sciences and Children's Hospital, Lahore: collaborator

Study Sites (1)

University of Child Health Sciences, The Children's Hospital, Lahore

Lahore, Punjab Province, 54300, Pakistan

RECRUITING

MeSH Terms

Conditions

Biliary Atresia; Choledochal Cyst

Interventions

Enhanced Recovery After Surgery

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cysts; Neoplasms

Intervention Hierarchy (Ancestors)

Perioperative Care; Surgical Procedures, Operative

Study Officials

• Sundas Zahra, MBBS

  University of Child Health sciences & The Children's Hospital, Lahore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sundas Zahra, MBBS

CONTACT

+923400686300; sundaszahra1080@gmail.com

Muhammad Zubair Shoukat, MBBS, FCPS Pediatric Surgery

CONTACT

03126446646; zubairshaukat@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 13, 2026
• First Posted: July 16, 2026
• Study Start: July 27, 2024
• Primary Completion: July 1, 2026
• Study Completion: August 1, 2026
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

PA (1)