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CTRI Number  CTRI/2025/03/082968 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 20/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative Study of EUS-Guided Choledochoduodenostomy vs. ERCP with FCSEMS for Preoperative Biliary Drainage 
Scientific Title of Study   EUS-guided choledochoduodenostomy vs ERCP FCSEMS for preoperative biliary drainage in malignant biliary obstruction: A randomised controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Praveer Rai 
Designation  Professor 
Affiliation  Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India 
Address  Room no 302, Department of Gastroenterology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904781  
Fax    
Email  praveer_rai@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kartik Agarwal  
Designation  Senior Resident  
Affiliation  Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India 
Address  Room no 305, Department of Gastroenterology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904789  
Fax    
Email  drkartik91@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Praveer Rai 
Designation  Professor 
Affiliation  Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India 
Address  Room no 302, Department of Gastroenterology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904781  
Fax    
Email  praveer_rai@yahoo.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research Department of Health Research, Ministry of Health and Family Welfare, Government of India, 110029 
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India, 226014 
 
Primary Sponsor  
Name  Dr Praveer Rai 
Address  Professor Department of Gastroenterology,C Block SGPGIMS, Raibareilly Road, Lucknow.UP.INDIA.226014,Phone:0522-2494428 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Praveer Rai  Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow  WARD A AND WARD B Department of Gastroenterology
Lucknow
UTTAR PRADESH 
8004904781

praveer_rai@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee(IEC) SGPGI, LUCKNOW  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  ERCP FCSEMS   In this procedure, transpapillary FCSEMS will be placed to relieve biliary obstruction. After 4 weeks patients will undergo surgery.  
Intervention  EUS guided Choledochoduodenostomy   In this procedure, a partially covered metal stent will be placed through the duodenums first part to dilate the common bile duct. After 4 weeks patients will undergo surgery.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Radiological diagnosis (with or without pathological confirmation) of resectable malignant biliary obstruction at least 2 cm distal to the hilum
2. Elevated liver tests with serum bilirubin > 3 ULN and dilated extra-hepatic bile duct measuring at least 1.2 cm on axial imaging or US.
3. ECOG less than or 2
4. Provision of informed consent
5. No serious or uncontrolled coexisting medical illness
 
 
ExclusionCriteria 
Details  1. Uncorrectable coagulopathy and/or thrombocytopenia (INR>1.5, PLT < 50,000)
2. Age < 18
3. Liver metastasis
4. Liver cirrhosis with portal hypertension or ascites
5. Prior biliary sphincterotomy or stent placement
6. Gastric outlet obstruction
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Successful surgery without reintervention rate between two groups  4 Weeks after biliary drainage 
 
Secondary Outcome  
Outcome  TimePoints 
1. Technical success: defined as the successful placement of a stent
2. Clinical success: defined as a 50% decrease in bilirubin 2 weeks post stent insertion or less than 25% of pre-procedure bilirubin level within 4 weeks post stent insertion
3. Rate of reintervention
4. Stent Patency: defined as the mean time to stent obstruction or migration
5. Early adverse events (within 14 days of index procedure) as defined include postprocedural bleeding, intestinal perforation, and cholangitis
6. Delayed adverse events (greater than 14 days of index procedure until last follow-up or death)
7. Endoscopic procedure time: defined as from insertion of the endoscope to endoscope withdrawal
8. Operation times
9. Intraoperative blood loss
10. Number of days of hospitalisation during surgery
11. Postoperative adverse events are defined according to the Clavien-Dindo classification
 
Clinical success at 2 weeek, Early adverse events with in 2 week after index procedure, Late adverse events after 2 week of procedure or till last follow up 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Malignant biliary obstruction (MBO) is usually caused by pancreatic tumours, cholangiocarcinoma, ampullary cancer, and metastatic cancer. Preoperative biliary decompression remains mandatory in cholangitis, need for neoadjuvant/induction chemotherapy, severe jaundice, severe pruritus and tumour preoperative work-up (1). Preoperative biliary drainage can be performed either endoscopically or percutaneously. Endoscopic methods include ERCP, and endoscopic ultrasound-guided biliary drainage (EUS-BD) (2).

Trans papillary stent placement with endoscopic retrograde cholangiopancreatography (ERCP) has been the preferred treatment modality for the treatment of malignant distal biliary obstruction (3). Major complications associated with the trans papillary route include the risk of post-ERCP pancreatitis and stent dysfunction secondary to tumour tissue ingrowth or overgrowth.

More recently, EUS-BD has emerged as an effective and alternate method for biliary drainage in cases of unsuccessful  ERCP. EUS-BD through the transluminal approach creates a biliary bypass with a stent through the duodenal bulb (choledochoduodenostomy) or stomach (hepaticogastrostomy). It permits accessing the biliary duct in patients with duodenal invasion or surgically-altered anatomy. It avoids ERCP-related complications, such as pancreatitis and post-sphincterotomy bleeding and does not involve traversing the biliary stricture, which decreases the risk of tumour ingrowth and reduces the probability of reintervention.

EUS-guided procedures have been conventionally restricted to inoperable patients, for fear of interference with eventual surgery. There are currently no guidelines for the optimal duration of preoperative biliary drainage (PBD). Delay due to PBD can lead to more advanced disease at the time of surgical resection and affect survival. In a randomised controlled study of 180 patients with pancreatic cancer, the mean time to surgery was 5.1 weeks in the PBD group and 1.2 weeks for patients who underwent early surgery (4). The biliary drainage duration of 4–6 weeks has been the goal before surgery (5,6).

In routine practice, time to surgery after PBD is affected by several factors including neoadjuvant therapy, cholangitis, and patient-related factors such as malnutrition and comorbidities.

To date, only a small volume of retrospective studies comparing EUS-BD with conventional ERCP exists and there is a lack a well-designed prospective study with robust data (7–9). The major limitations of trials are, small sample size, underpowered and single-centre studies, thus limiting the generalizability of the findings.

 
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