Choledochal Cyst ResectionNCT07709702
ERAS in Choledochal Cyst & Biliary Atresia
A study testing Enhanced Recovery After Surgery and Post-operative care in people with Choledochal Cyst Resection and Biliary Atresia, Kasai Portoenterostomy Status, run by Muhammad Zubair Shoukat at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 14 years
- Conditions the study is for
- Choledochal Cyst Resection, Biliary Atresia, Kasai Portoenterostomy Status
- What is being tested?
- Enhanced Recovery After Surgery and Post-operative care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Jul 2024to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
University of Child Health Sciences, The Children's Hospital, Lahore
Lahore, Punjab Province, 54300
About this study
Official title: Early Oral Feeding Versus Conventional Feeding After Surgery for Biliary Atresia and Choledochal Cyst: A Randomized Controlled Trial
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.
Read more
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.
- Being tested
- Enhanced Recovery After Surgery, Post-operative care
- Keywords
- ERAS, Choledochal Cyst, Pediatric, Children, Post-Operative Management, Biliary Atresia, Feeding Protocol, Fast-Tract Discharge, Hospital Stay
- Medical subject headings
- Biliary Atresia, Choledochal Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Recovery After SurgeryOther
Also called Fast-tract feeding protocol, Early oral feeding
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.
Post-operative careOther
Also called Conventional Feeding Protocol
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: 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. Receives: 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) Receives: Other: Post-operative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Infection
Condition characterized with presence of redness, swelling, warmth, pain or purulent discharge from surgical site classified according to CDC SSI grading.
Measured: 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
Measured: Within hospital stay or on readmission within 1 month
Length of Hospital Stay
Duration of stay measured in days
Measured: From the date of surgery until the date of hospital discharge, assessed up to 30 days
Secondary outcomes (3)
Vomiting
episodes of vomiting after surgery
Measured: From start of feeding till 30 days post-operatively
Abdominal Distension
Development of signs of abdominal distension on clinical examination leading to decision of holding feeds
Measured: from initiation of oral feeds till 30 days post-operatively
Need for Re-operation
Any sugical intervention required for post operative complications like wound infection or anastomotic leak or other previously unspecified reasons
Measured: From start of oral feeds till 04 weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start27 Jul 2024
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choledochal Cyst ResectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muhammad Zubair Shoukat
- Sponsor type
- University, hospital or other
- Collaborators
- University of Child Health Sciences and Children's Hospital, Lahore
- Responsible party
- Sponsor-investigator, Muhammad Zubair Shoukat, University of Child Health Sciences and Children's Hospital, Lahore
- Investigators
- Sundas Zahra, MBBS, Principal investigator, University of Child Health sciences & The Children's Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709702
- Sponsor's protocol ID
- 1139/CH-UCHS
- Status last verified
- Jul 2026
- First submitted
- 13 Jun 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Oral Feeding Versus Conventional Feeding After Surgery for Biliary Atresia and Choledochal Cyst: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07709702
- Acronym / sponsor ID
- 1139/CH-UCHS
- Keywords
- ERAS, Choledochal Cyst, Pediatric, Children, Post-Operative Management, Biliary Atresia, Feeding Protocol, Fast-Tract Discharge
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Muhammad Zubair ShoukatUniversity, hospital or other
- Collaborators
- University of Child Health Sciences and Children's Hospital, Lahore
- Study start
- 27 Jul 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ERAS Feeding Protocol in Choledochal Cyst | Experimental | Other: Enhanced Recovery After SurgeryThe 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 |
| Conventional Feeding Protocol in Choledochal Cyst | Active comparator | Other: Post-operative careThe 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) |
| ERAS in Biliary Atresia | Experimental | Other: Enhanced Recovery After SurgeryPost-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. |
| Conventional feeding protocol in Biliary Atresia | Active comparator | Other: Post-operative carePost-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) |
Who may qualify
- Ages
- 1 month to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Recovery After SurgeryAlso: Fast-tract feeding protocol, Early oral feedingIn 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. | Other | ERAS Feeding Protocol in Choledochal Cyst, ERAS in Biliary Atresia |
| Post-operative careAlso: Conventional Feeding ProtocolIn 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 | Other | Conventional Feeding Protocol in Choledochal Cyst, Conventional feeding protocol in Biliary Atresia |
Primary outcome
Wound Infection
Time frame: Within 04 weeks of surgery
Condition characterized with presence of redness, swelling, warmth, pain or purulent discharge from surgical site classified according to CDC SSI grading.
Anastomotic Leak
Time frame: Within hospital stay or on readmission within 1 month
When surgical anastomosis fails and there is leakage proven with signs of peritonitis on clinical examination, pneumoperitoneum on radiographs
Length of Hospital Stay
Time frame: From the date of surgery until the date of hospital discharge, assessed up to 30 days
Duration of stay measured in days
3 secondary outcomes
Vomiting
Time frame: From start of feeding till 30 days post-operatively
Abdominal Distension
Time frame: from initiation of oral feeds till 30 days post-operatively
Need for Re-operation
Time frame: From start of oral feeds till 04 weeks post-op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Choledochal Cyst Resection
Not yet recruiting
Clinical Trial on Safety and Efficacy of Thoracoabdominal Endoscopic Surgical System for Pediatric Surgery
Indications for Laparoscopic Thoracic and Abdominal Surgery in Children, Congenital or Acquired Surgical Conditions Requiring Minimally Invasive Surgery in Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sundas Zahra, MBBS principal investigator
University of Child Health sciences & The Children's Hospital, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Recovery After Surgery and Post-operative care in people with Choledochal Cyst Resection and Biliary Atresia, Kasai Portoenterostomy Status, run by Muhammad Zubair Shoukat at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sundas Zahra, MBBS (+923400686300, sundaszahra1080@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Infection (time frame: Within 04 weeks of surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.