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
|
|
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
|
|
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. |