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CTRI Number  CTRI/2024/12/077821 [Registered on: 09/12/2024] Trial Registered Prospectively
Last Modified On: 02/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Endoscopic ]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of the performance of two different stent types, viz lumen apposing metal stent and tubular stent while performing endoscopic ultrasound-guided drainage of the obstructed bile duct in patients with distal block of the bile duct due to malignancy.  
Scientific Title of Study   Lumen apposing metal stents versus Covered tubular self-expanding metal stents for EUS-guided choledochoduodenostomy In Distal malignant biliary obstruction: A randomized controlled trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jayanta Samanta 
Designation  Associate Professor 
Affiliation  Postgraduate Institute of Medical Education and Research, Chandigarh 
Address  Department of Gastroenterology, PGIMER, Chandigarh Sector-12

Chandigarh
CHANDIGARH
160012
India 
Phone  9855319529  
Fax    
Email  dj_samanta@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Jayanta Samanta 
Designation  Associate Professor 
Affiliation  Postgraduate Institute of Medical Education and Research, Chandigarh 
Address  Department of Gastroenterology, PGIMER, Chandigarh Sector-12


CHANDIGARH
160012
India 
Phone  9855319529  
Fax    
Email  dj_samanta@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Jayanta Samanta 
Designation  Associate Professor 
Affiliation  Postgraduate Institute of Medical Education and Research, Chandigarh 
Address  Department of Gastroenterology, PGIMER, Chandigarh Sector-12


CHANDIGARH
160012
India 
Phone  9855319529  
Fax    
Email  dj_samanta@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Gastroenterology, Nehru Hospital, Postgraduate Institute of Medical Education and Research, Chandigarh Sector - 12 Chandigarh - 160012  
 
Primary Sponsor  
Name  Jayanta Samanta 
Address  Room -20, Block F, Level I Department Of Gastroenterology, Nehru Hospital, PGIMER, Chandigarh, Sector-12 Chandigarh - 160012  
Type of Sponsor  Other [Self] 
 
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 Sundeep Lakhtakia  Asian Institute of Gastroenterology  Department of Gastroenterology, Asian Institute of Gastroenterology, Gachibowli Hyderabad
Hyderabad
TELANGANA 		 9848040629

drsundeeplakhtakia@gmail.com 
Dr Jayanta Samanta   Postgraduate Institute of Medical Education and Research, Chandigarh  Department of Gastroenterology, Nehru Hospital, PGIMER, Chandigarh Sector-12
Chandigarh
CHANDIGARH 		 9855319529

dj_samanta@yahoo.co.in 
Dr Praveer Rai  Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow  Department of Gastroenterology, SGPGI, Raebareli Road, Lucknow - 226014
Lucknow
UTTAR PRADESH 		 9235630450

praveer_rai@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee, Asian Institute of Gastroenterology, Hyderabad  Approved 
Institutional Ethics Committee, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow  Approved 
Postgraduate Institute of Medical Education and Research, Chandigarh, Institutional Ethics Committee  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  EUS CDS using lumen apposing metal stent  After informed consent and randomization, the patients will be subjected to EUS-guided biliary drainage by choledochoduodenostomy (EUS-CDS) using cautery enhanced lumen apposing metal stents (EC-LAMS). A linear echoendoscope will be used and positioned in the bulb of the duodenum with the direction of the probe towards the hilum for EUS-CDS. For EC-LAMS, it can be performed by either the free-hand technique without the use of guidewire or by the guidewire directed placement. For the guidewire assisted technique, a 19 G FNA needle will be used to puncture the extrahepatic bile duct. After the needle puncture, bile will be aspirated to confirm position. Cholangiogram will be obtained subsequently. An 0.035-inch guidewire will be directed proximally into the intrahepatic biliary tree rather than crossing the distal site of obstruction. The needle will then be removed while maintaining access with the wire, and the EC-LAMS will be used to place the stent over the wire. Care should be taken to place the LAMS distal to the opening of the cystic duct. The patients will be followed up for a period of 6 months for the outcomes.  
Comparator Agent  EUS-CDS using tubular metal stents   After informed consent and randomization, the patients will be subjected to EUS-guided biliary drainage by choledochoduodenostomy (EUS-CDS) using tubular stents A linear echoendoscope will be used and positioned in the bulb of the duodenum with the direction of the needle towards the hilum for EUS-CDS. A 19 G FNA needle will be used to puncture the extrahepatic bile duct. After the needle puncture, bile will be aspirated to confirm position. Cholangiogram will be obtained subsequently. An 0.035-inch guidewire will be directed proximally into the intrahepatic biliary tree rather than crossing the distal site of obstruction. The needle will then be removed while maintaining access with the wire, and the tract will be dilated using a cystotome. Finally, a tubular metal stent will be deployed with one end in bile duct and the other one in the duodenum, creating a choledocho-duodenostomy. Care should be taken to place the proximal end of the SEMS distal to the opening of the cystic duct. The patients will be followed up for a period of 6 months for the outcomes.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  malignant distal biliary obstruction
naive/prior ERCP failure or unsuccessful ERCP
informed consent 
 
ExclusionCriteria 
Details  hilar or proximal biliary obstruction
altered GI anatomy
Unfit for endoscopic procedure
uncorrectable coagulopathy or thrombocytopenia
pregnancy 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Rates of re-intervention for recurrent biliary obstruction   6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Technical success
2. Clinical success
3. Effective biliary drainage (EBD)
4. Rates of adverse events
5. Duration of hospital stay
6. Procedure time
7. Time to develop recurrent biliary obstruction (1,3,6 months)
8. Evaluation of stent patency (1,3,6 months) or if stent dysfunction occurs (whichever is earlier)
 		 1. Technical Success, procedure time at the time of procedure
2. Clinical Success and EBD at 1 month
3. Duration of hospital stay at index admission
4. time to RBO and stent patency at 1, 3 , 6 months

 
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   16/12/2024 
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="1"
Days="1" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dj_samanta@yahoo.co.in].

  6. For how long will this data be available start date provided 31-12-2027 and end date provided 31-12-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   The gold standard for the management of malignant distal biliary obstruction (MDBO) has been endoscopic retrograde cholangiopancreatography (ERCP). Despite the advancements in endoscopic accessories and techniques, failure to cannulate may be present in 4-16% cases. In such cases, patients are salvaged with percutaneous transhepatic biliary drainage (PTBD) or surgery. Both salvage modalities have their own shortcomings. An alternative to these which has gained momentum in MBO management has been endoscopic ultrasound guided biliary drainage (EUS-BD). For MDBO, EUS-guided choledochoduodenostomy (EUS-CDS) or EUS-guided hepaticogastrostomy can be done. For EUS-CDS, it is more technically easier and can be done by either tubular metal stents (SEMS) or cautery enhanced lumen apposing metal stents (EC-LAMS). Both these stents has their own set of pros and cons. But which metal stent to prefer (SEMS versus EC-LAMS) for EUS-CDS is still debatable. We hypothesized that, while EC-LAMS and SEMS would be equally effective and safe, the rates of stent dysfunction/block requiring re-intervention would be different between the two arms considering the inherent difference in the design of the two stents. Thus, this study has been planned to compare EC-LAMS versus covered tubular SEMS in EUS-CDS in terms of clinical efficacy, safety, and re-intervention rates. 
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