| CTRI Number |
CTRI/2024/02/062850 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
20/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
|
Comparison of Endoscopic ultrasound and ERCP guided biliary drainage |
|
Scientific Title of Study
|
EUS versus ERCP guided biliary drainage for primary palliation of malignant biliary obstruction: A Randomized Clinical Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahul Yadav |
| Designation |
Senior Resident |
| Affiliation |
AIIMS RISHIKESH |
| Address |
Department of Gastroenterology, Level 6, All India Institute of Medical Sciences, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8860385992 |
| Fax |
|
| Email |
rahulyadav385992@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Itish Patnaik |
| Designation |
Associate Professor |
| Affiliation |
AIIMS RISHIKESH |
| Address |
Department of Gastroenterology, Level 6, Academic Block, All India Institute of Medical Sciences, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8825564938 |
| Fax |
|
| Email |
patnaik.itish@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Itish Patnaik |
| Designation |
Associate Professor |
| Affiliation |
AIIMS RISHIKESH |
| Address |
Department of Gastroenterology, Level 6, Academic Block, All India Institute of Medical Sciences, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8825564938 |
| Fax |
|
| Email |
patnaik.itish@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Rishikesh |
| Address |
AIIMS Rishikesh, Veerbhadra Road, Rishikesh,
249203 |
| Type of Sponsor |
Government medical college |
|
|
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 yadav |
AIIMS Rishikesh |
Department of medical gastroenterology, level 6, All India Institute of Medical Sciences (AIIMS), Rishikesh, veerbhadra road, Rishikesh
Dehradun
UTTARANCHAL |
8860385992
rahulyadav385992@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences, Rishikesh Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K831||Obstruction of bile duct, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ERCP GUIDED BILIARY DRAINAGE |
ERCP will be performed in prone position using a standard adult duodenoscope (TJF-180 Olympus Japan).Biliary cannulation will be done by wire guided technique using a sphincterotome. Bile will be aspirated to confirm biliary cannulation. After confirmation of successful bile duct cannulation, biliary sphincterotomy will be performed. Finally, a uncovered or fully covered self-expandable metal stent will be placed across the papilla and the biliary stricture. After placement of the stent the flow of the bile across the stent will be noted and patient will be followed by serial Liver function tests at post procedure day 3,7,14,28 to look for fall in bilirubin and resolution of the cholangitis |
| Intervention |
EUS GUIDED BILIARY DRAINAGE |
DRAINAGE BY PLACING METAL STENT BY EUS GUIDED TECHNIQUE.
Patient with periampullary neoplasm and pancreatic head cancer causing biliary obstruction will undergo choledochoduodenostomy (placing a stent from duodenum to common bile duct). Patients with obstruction proximal to the pancreas with a patent confluence will undergo hepaticogastrostomy (placement of stent from stomach to a branch of left hepatic duct). In cases of distal obstruction where suitable window for CDS (due to collaterals or compromised duodenal bulb or low insertion of the cystic duct) not available will be considered for Hepaticogastrostomy. After placement of the stent the flow of the bile across the stent will be noted and patient will be followed by serial Liver function tests at post procedure day 3,7,14,28 to look for fall in bilirubin and resolution of the cholangitis |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Radiological diagnosis (with or without pathological confirmation) of malignancy and presence of a malignant subhilar (at least 2cm distal to hilum) biliary obstruction and dilation of the upstream bile duct that is unresectable or the patient is inoperable due to high surgical risk as decided by the treating surgeon |
|
| ExclusionCriteria |
| Details |
1-Age less than 18 years
2-Hilar biliary obstruction
3-Grade 3 cholangitis
4-Poor performance status
5-Pregnancy
6-Post biliary sphincterotomy status
7-Prior duodenal self-expanding metal stent
8-Liver metastasis of more than 30 % of liver volume
9-Gastric outlet obstruction
10-Prior ERCP and EUS with a stent in situ
11-Moderate to severe ascites on imaging
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the technical success of ERCP and EUS guided biliary drainage for primary drainage of unresectable subhilar malignant biliary obstruction. Technical success is defined as placement of metal stent and visual confirmation of flow of bile immediately after placing stent. |
baseline (preprocedure)and immediately after placement of stent |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1-Procedure time-time (in mins) from the puncture of the bile duct to stent placement in the EUS-BD group, & from the time of biliary cannulation to stent placement in the ERCP group.
2-Clinical success- improvement in T-Bilirubin to less than 50% of the highest pretreatment values within 14 days after stent placement or less than 25% of the highest pretreatment values within 4 weeks and/or resolution of cholangitis if present preprocedure.
3-Duration of hospital stay- from placement of stent till discharge/death.
4-Procedure related adverse events- Adverse events attributable to a procedure within 14 days of the procedure.
5-Stent dysfunction rate- reappearance of cholangitis after resolution or increase in bilirubin by 50% from lowest level.
6- Stent patency - mean time in days from index procedure to stent dysfunction or migration
7- Reintervention rate- need for additional intervention within 1 month of the index procedure
|
baseline, post procedure day 3,7,14,28 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
21/02/2024 |
| 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="1"
Months="2"
Days="0" |
|
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 - NO
|
|
Brief Summary
|
The trial is to compare the technical success rate of both ERCP guided and EUS guided biliary drainage in patients of malignant inoperable biliary obstruction. additional objectives will also be studied like stent patency rate of metal stents between two groups and stent dysfunction
|