CClinicalTrials.gg
RecruitingNCT07709702Updated Jul 16, 2026

ERAS in Choledochal Cyst & Biliary Atresia

An interventional study of Enhanced Recovery After Surgery and Post-operative care in Choledochal Cyst Resection and Biliary Atresia, Kasai Portoenterostomy Status, sponsored by Muhammad Zubair Shoukat. Recruiting at 1 site in Pakistan. Open to participants aged 1 Month to 14 Years. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by Muhammad Zubair Shoukat · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
1 Month to 14 Years
Sex
All
01

Study 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.

Read the detailed description

Enhanced Recovery After Surgery (ERAS) pathways are evidence-based, multidisciplinary perioperative care protocols designed to reduce surgical stress, maintain physiological function, accelerate recovery, improve patient outcomes, and reduce healthcare costs. Early enteral nutrition is a key component of ERAS programs and has been associated with improved gastrointestinal recovery, reduced postoperative morbidity, and shorter hospital stay across multiple surgical specialties.

The role of early oral feeding following pediatric hepatobiliary surgery remains insufficiently studied, particularly in low- and middle-income countries. Biliary atresia and choledochal cysts are among the most common pediatric hepatobiliary disorders requiring major reconstructive surgery. Postoperative feeding practices vary considerably, and many centers continue to delay oral intake until bowel sounds return or passage of stool occurs. However, delayed feeding may prolong recovery, increase dependence on intravenous fluids, and extend hospitalization.

This prospective randomized controlled trial will be conducted at the Department of Paediatric Surgery, University of Child Health Sciences and The Children's Hospital Lahore. The study aims to compare early oral feeding with conventional postoperative feeding in children undergoing surgery for biliary atresia and choledochal cyst.

A total of 46 eligible patients will be enrolled and randomized equally into two groups. Children aged up to 14 years undergoing elective surgery for Type I or Type IV choledochal cyst and infants up to 3 months of age undergoing surgery for biliary atresia will be considered for inclusion. Patients with preoperative malnutrition, hypoalbuminemia, emergency procedures, external cyst drainage, or those not undergoing portoenterostomy after operative cholangiography will be excluded.

All enrolled participants will receive standardized perioperative care. In the intervention group, oral clear liquids will be initiated within 24 hours after surgery and advanced progressively to semisolid and full feeds according to tolerance. In the control group, oral feeding will commence after more than 48 hours postoperatively, following clinical evidence of return of bowel function, including passage of stool or flatus.

Patients will be monitored for postoperative complications including anastomotic leakage, surgical site infection, vomiting, abdominal distension, need for nasogastric tube reinsertion, and requirement for reoperation. Discharge criteria will be standardized for both groups and include stable vital signs, adequate oral intake, satisfactory bowel function, and surgeon approval.

The primary outcomes will be postoperative hospital stay, anastomotic leakage, and surgical site infection. Secondary outcomes will include time to initiation of feeds, time to full feeding, gastrointestinal tolerance, nasogastric tube reinsertion, postoperative complications, and need for repeat surgical intervention.

Data will be analyzed using SPSS version 26. Continuous variables will be reported as mean, median, and standard deviation, while categorical variables will be presented as frequencies and percentages. Comparisons between groups will be performed using independent sample t-tests or Chi-square tests as appropriate, with statistical significance defined as a p-value ≤0.05.

This study seeks to generate local evidence regarding the safety and effectiveness of early postoperative feeding following pediatric hepatobiliary surgery. The findings may support implementation of ERAS principles in pediatric surgical practice and contribute to improved recovery, reduced hospitalization, and more efficient utilization of healthcare resources.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
1 Month to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. 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
  2. patients with history of Emergency surgery or external drainage of choledochal cyst
  3. Hemodynamically unstable patients after surgery
  4. Previous history of GI surgery
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    ERAS Feeding Protocol in Choledochal Cyst

    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

  • Active comparator
    Conventional Feeding Protocol in Choledochal Cyst

    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

  • Experimental
    ERAS in Biliary Atresia

    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

  • Active comparator
    Conventional feeding protocol in Biliary Atresia

    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

  • OtherEnhanced Recovery After Surgery

    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

  • OtherPost-operative care

    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

05

What researchers measure

Primary outcomes

  1. Wound Infection

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

    Time frame: Within 04 weeks of surgery

  2. Anastomotic Leak

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

    Time frame: Within hospital stay or on readmission within 1 month

  3. Length of Hospital Stay

    Duration of stay measured in days

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

Secondary outcomes

  1. Vomiting

    episodes of vomiting after surgery

    Time frame: From start of feeding till 30 days post-operatively

  2. Abdominal Distension

    Development of signs of abdominal distension on clinical examination leading to decision of holding feeds

    Time frame: from initiation of oral feeds till 30 days post-operatively

  3. Need for Re-operation

    Any sugical intervention required for post operative complications like wound infection or anastomotic leak or other previously unspecified reasons

    Time frame: From start of oral feeds till 04 weeks post-op

06

Study locations

1 of 1 sites recruiting
  • University of Child Health Sciences, The Children's Hospital, Lahore
    Lahore, Punjab Province 54300, Pakistan
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07709702
Lead sponsor
Muhammad Zubair Shoukat
Collaborators
University of Child Health Sciences and Children's Hospital, Lahore
Responsible party
Muhammad Zubair Shoukat (Dr., University of Child Health Sciences and Children's Hospital, Lahore) — Sponsor-investigator
First posted
Jul 16, 2026
Start date
Jul 27, 2024
Primary completion
Jul 2026 (estimated)
Completion
Aug 2026 (estimated)
Last update
Jul 16, 2026

Study contacts

Sundas Zahra, MBBS
Contact
sundaszahra1080@gmail.com
+923400686300
Muhammad Zubair Shoukat, MBBS, FCPS Pediatric Surgery
Contact
zubairshaukat@outlook.com
03126446646
Sundas Zahra, MBBS
principal investigator · University of Child Health sciences & The Children's Hospital, Lahore

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion