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CTRI Number  CTRI/2021/10/037018 [Registered on: 01/10/2021] Trial Registered Prospectively
Last Modified On: 30/09/2021
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Endoscopy guided drainage of the bile duct for obstructive jaundice 
Scientific Title of Study   EUS trans papillary or trans luminal biliary stenting for malignant biliary obstruction- a prospective randomised comparison 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rahul Shah 
Designation  Consultant 
Affiliation  SL Raheja Hospital 
Address  IDL Care, SL Raheja Hospital, Mumbai
Mahim, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400016
India 
Phone  9820190508  
Fax    
Email  rahulhshah@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rahul Shah 
Designation  Consultant 
Affiliation  SL Raheja Hospital 
Address  IDL Care, SL Raheja Hospital, Mumbai
Mahim, Mumbai

MAHARASHTRA
400016
India 
Phone  9820190508  
Fax    
Email  rahulhshah@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rahul Shah 
Designation  Consultant 
Affiliation  SL Raheja Hospital 
Address  IDL Care, SL Raheja Hospital, Mumbai
Mahim, Mumbai

MAHARASHTRA
400016
India 
Phone  9820190508  
Fax    
Email  rahulhshah@hotmail.com  
 
Source of Monetary or Material Support  
Standard of care for failed ERCP. Patient will self fund it 
 
Primary Sponsor  
Name  SL Raheja Hospital 
Address  IDL Care, SL Raheja Hospital, Mahim, Mumbai 
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 Rahul Shah  SL Raheja Hospital  IDL Care, SL Raheja Hospital, Mahim, Mumbai
Mumbai (Suburban)
MAHARASHTRA 
9820190508

rahulhshah@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  EUS guided stenting  Patients with inoperable malignant biliary obstruction requiring biliary drainage after a failed ERCP will be randomized to receive an expandable stent by either EUS-AG or EUS-HGS. Their outcomes will be recorded 
Intervention  EUS guided stenting  Patients with inoperable malignant biliary strictures requiring biliary drainage after a failed ERCP will be randomised to EUS guided AG or EUS -HGS stenting  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Diagnosis of pancreatic cancer, distal common bile duct (CBD) cholangiocarcinoma, ampullary cancers , hilar blocks, other metastatic conditions eg LN mets, Lymphoma)
• Biliary obstructive symptoms or signs
• Bilirubin level/ alkaline phosphatase level above normal limits
• Patients deemed as unresectable by CT / MRI / PET
• Patients with failed ERCP or anticipated difficult ERCP
 
 
ExclusionCriteria 
Details  Biliary strictures caused by confirmed benign tumours
• Neoadjuvant chemotherapy for current malignancy
• Palliative indication due to reasons other than surgical candidate status
• Previous biliary drainage by ERCP/PTC
• Patients for whom endoscopic techniques are contraindicated
• Participation in another investigational trial within 180 days
• Pregnancy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
We hypothesize that the stent patency via trans-luminal route is better than that via trans-papillary route.
The primary aim of the study is to compare the stent patency in patients undergoing EUS guided antegrade procedure and EUS-guided HGS.

 
3, 6 months
 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary aim is to compare the short and long term adverse events of the two procedures  3, 6 months 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   01/10/2021 
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)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

EUS guided bile duct drainage (EUS-BD) has been well established as an alternative to ERCP for bile duct drainage. This encompasses EUS-CDS, EUS-HGS EUS – Antegrade stenting and EUS-RV. With evolving expertise in EUS, emerging technological and stent advances, EUS-BD has become a viable first line alternative to ERCP  in expert hands. EUS guided biliary interventions have become much more acceptable in recent times with several randomised controlled trials proving the clinical efficacy, safety and success . What is unknown is the preferred route of drainage- Is trans-papillary drainage safer than trans-luminal route nor do we have data on the stent patency of the trans papillary route vs. trans-luminal route?  Trans papillary drainage is well into its 5th decade with acceptable complication rates, with well-known short and long term results and negligible chances of bile leak. However there is a significant chance of pancreatitis and wire manipulation may be difficult. Trans luminal stenting is safe in expert hands with little chance of pancreatitis, shorter procedure times. The disadvantage being higher chance of bile leak (? exaggerated risk) and the prohibitory cost of the stents.

Hypothesis:

We hypothesize that the stent patency via trans-luminal route is better than that via trans-papillary route. 

Possible adverse event and its treatment

GI tract damage

                Gastric haemorrhage or perforation

                Surgical operation may be required.

Stent migration

                Abdominal pain and fever accompanied by elevation of inflammation.

                Surgical operation may be required.

 

 Conclusion:

To evaluate safety and long term outcomes of such EUS guided procedures



 
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