FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/02/103236 [Registered on: 06/02/2026] Trial Registered Prospectively
Last Modified On: 06/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   ERCP stenting in benign biliary stricture for resolution of Jaundice 
Scientific Title of Study   “FULLY COVERED SEMS VS MULTIPLE PLASTIC STENTS VS COMBINED STENTS TO TREAT BENIGN BILIARY STRICTURES : A MULTICENTRIC RANDOMISED CONTROLLED TRIAL (COMBS TRIAL)” 
Trial Acronym  NILL  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashok Jhajharia 
Designation  Professor  
Affiliation  Sawai Man Singh Medical college  
Address  109 SHIV VIHAR VKI , IN FRONT OF ROAD 5 , SIKAR ROAD , 302039 , JAIPUR , RAJASTHAN , INDIA
ROOM NO 316 , GASTRO OFFICE , 3RD FLOOR , DEPARTMENT OF GASTROENTEROLOGY,SUPERSPECIALITY HOSPITAL , J.L.N Marg - 302004 JAIPUR , RAJASTHAN , INDIA
Jaipur
RAJASTHAN
302039
India 
Phone  09414236572  
Fax    
Email  drashokjhajharia@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashok Jhajharia 
Designation  Professor  
Affiliation  Sawai Man Singh Medical college  
Address  109 SHIV VIHAR VKI , IN FRONT OF ROAD 5 , SIKAR ROAD , 302039 , JAIPUR , RAJASTHAN , INDIA
ROOM NO 316 , GASTRO OFFICE , 3RD FLOOR , DEPARTMENT OF GASTROENTEROLOGY,SUPERSPECIALITY HOSPITAL , J.L.N Marg - 302004 JAIPUR , RAJASTHAN , INDIA
Jaipur
RAJASTHAN
302039
India 
Phone  09414236572  
Fax    
Email  drashokjhajharia@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashok Jhajharia 
Designation  Professor  
Affiliation  Sawai Man Singh Medical college  
Address  109 SHIV VIHAR VKI , IN FRONT OF ROAD 5 , SIKAR ROAD , 302039 , JAIPUR , RAJASTHAN , INDIA
ROOM NO 316 , GASTRO OFFICE , 3RD FLOOR , DEPARTMENT OF GASTROENTEROLOGY,SUPERSPECIALITY HOSPITAL , J.L.N Marg - 302004 JAIPUR , RAJASTHAN , INDIA
Jaipur
RAJASTHAN
302039
India 
Phone  09414236572  
Fax    
Email  drashokjhajharia@gmail.com  
 
Source of Monetary or Material Support  
BSBY, Tilak Marg C scheme 302005, SMS MEDICAL COLLEGE, JAIPUR ,RAJASTHAN, INDIA- 302004 
 
Primary Sponsor  
Name  BSBY 
Address  BSBY, Tilak Marg C scheme 302005, SMS MEDICAL COLLEGE, JAIPUR ,RAJASTHAN, INDIA- 302004 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashok Dalal  Govind Ballabh Pant Hospital  Dr Ashok Dalal , Professor of Gastroenterology, Room no 210, Academic block , 2nd floor , JLN Marg, Near Gate no 2 , New Delhi , 110002
Central
DELHI 		 9718599219

drashokdalal83@gmail.com 
Dr Jimil Shah   Post Graduate Institute of Medical Education and Research , Chandigarh , India  Room no 13 Department of Gastroenterology, F block , Nehru hospital , Postgraduate Institute of Medical Education and Research Chandigarh , Sector 12 , 160012
Chandigarh
CHANDIGARH 		 8655376773

drjimilgastro@gmail.com 
Dr Ashok Jhajharia  Sawai Man Singh Medical College Jaipur  ROOM NO 316 , GASTRO OFFICE , 3RD FLOOR , DEPARTMENT OF GASTROENTEROLOGY,SUPERSPECIALITY HOSPITAL , J.L.N Marg - 302004 JAIPUR , RAJASTHAN , INDIA
Jaipur
RAJASTHAN 		 09414236572

drashokjhajharia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE S.M.S MEDICAL COLLEGE JAIPUR  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 
Intervention  Endoscopic retrograde cholangiopancreatography (ERCP)  ERCP will be done in three groups with described intervention below. a) Fully covered Biliary SEMS b) Multiple plastic stents c) Combined stents (Fully covered biliary SEMS with internal anchoring plastic stent), duration of procedure shall be 1 year 
Comparator Agent  Endoscopic retrograde cholangiopancreatography (ERCP)  ERCP will be done in three groups with described intervention below. a) Fully covered Biliary SEMS b) Multiple plastic stents c) Combined stents (Fully covered biliary SEMS with internal anchoring plastic stent) duration of procedure shall be 1 year All 3 arms are intervention arm which shall be compared internally amongst each other 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1)Age group - greater than or equal to 18 years
2)Symptomatic bile duct stricture (defined by cholangitis or persistent jaundice {Total
bilirubin greater than or equal to 2.5mg/dl} for at least 1 month or persistent cholestasis associated with at least 3 times normal alkaline phosphatase levels) documented at time of enrolment for naive stricture or at the time of prior plastic stent placement in strictures that had 1 prior plastic stent inserted
3)Common bile duct stricture based on imaging assessment of dilatation of the common and/or
intrahepatic bile ducts.
4)Benign etiologies like chronic pancreatitis, post cholecystectomy and idiopathic. 
 
ExclusionCriteria 
Details  1)Malignant bile duct stricture
2)A prior biliary metal stent or more than 1 plastic stent for 6 months
3)Stricture within 2 cm of common bile duct bifurcation
4)Portal cavernous cholangiopathy,
5)Known bile duct fistula or leak,
6)Symptomatic duodenal stenosis with gastric stasis,
7)Contraindication to endoscopic techniques or devices,
8)Refusal to consent 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Safety profile and complication rates in all the 3 groups throughout the study period.  At end of 2 years 
 
Secondary Outcome  
Outcome  TimePoints 
To compare biliary stricture resolution 2 years after initial stent(s) defined as the absence of re-
stenting after the stenting period and 2 years serum alkaline phosphatase level not exceeding twice the level at the end of the stenting period. 		 at end of 2 years 
To compare the technical success and treatment failure of stent placement  At end of 2 years 
Number of endoscopic retrograde cholangiopancreatography (ERCP) procedures during
2 years after initial stent placement 		 At end of 2 years 
Total number of stents placed during the study and duration of stent placement procedure   
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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)   21/02/2026 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Endoscopy has become the preferred option for treating benign
biliary stricture (BBS). ESGE recommends temporary insertion
of either multiple plastic stents or a fully covered
SEMS(FCSEMS) for treatment of benign biliary strictures. The
choice between the two strategies depends on the etiology of the
stricture, its location, the CBD diameter, and the endoscopist’s
experience.
The study primarily aims to statistically evaluate and compare
the safety profile and complication rates in all the three groups
throughout the study period. The study secondarily also aims to
compare the biliary stricture resolution 2 years after initial
stent(s)placement defined as the absence of re-stenting after the
stenting period and 2 years serum alkaline phosphatase (ALP)
level not exceeding twice the level at the end of stenting period, technical success and
treatment failure of stent placement, number of endoscopic
retrograde cholangiopancreatography (ERCP) procedures
during 2 years after initial stent placement, total number of
stents placed during the study and duration of stent placement
procedure.
 
Close