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
|
|
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
|
|
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
|