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CTRI Number  CTRI/2024/12/077547 [Registered on: 02/12/2024] Trial Registered Prospectively
Last Modified On: 28/11/2024
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 two strategies of relieving bile duct obstruction before surgery in patients with distal malignant bile duct obstruction - endoscopic ultrasound guided technique versus the conventional endoscopic retrograde cholangiography  
Scientific Title of Study   Preoperative biliary drainage in patients with Distal REsectAble and borderline resectable Malignant biliary obstruction by primary Endoscopic ultrasound guided choledochoduodenostomy versus Endoscopic retrograde cholangiopancreatography: a randomized controlled trial  
Trial Acronym  DREAMEE 
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  PGIMER, Chandigarh 
Address  Department of Gastroenterology, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9855319529  
Fax  91-172-2744401  
Email  dj_samanta@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Jayanta Samanta 
Designation  Associate Professor 
Affiliation  PGIMER, Chandigarh 
Address  Department of Gastroenterology, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9855319529  
Fax  91-172-2744401  
Email  dj_samanta@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Jayanta Samanta 
Designation  Associate Professor 
Affiliation  PGIMER, Chandigarh 
Address  Department of Gastroenterology, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9855319529  
Fax  91-172-2744401  
Email  dj_samanta@yahoo.co.in  
 
Source of Monetary or Material Support  
National Cancer Grid, Tata Memorial Hospital, 10th Floor, Homi Bhabha Block, Dr. Ernest Borges Rd, Parel East, Mumbai 400012 
 
Primary Sponsor  
Name  National Cancer Grid Mumbai 
Address  National Cancer Grid Tata Memorial Hospital, 10th Floor, Homi Bhabha Block, Dr. Ernest Borges Rd, Parel East, Mumbai 400012 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Soumya Jagannath Mahapatra  All India Institute of Medical Sciences, New delhi  Department of Gastroenterology and Human Nutrition AIIMS, New Delhi Ansari Nagar, New delhi
North East
DELHI 		 9990420767

soumyajagannath@yahoo.com 
Zaheer Nabi  Asian Institute of Gastroenterology  Department of Gastroenterology, 6-3-661, Somajiguda, Hyderabad AIG, Hyderabad
Hyderabad
TELANGANA 		 9573058810

zaheernabi1978@gmail.com 
Siddharth Srivastava  Maulana Azad Medical College and Associated Hospital  Department of Gastroenterology Maulana Azad Medical College and Associated GIPMER New Delhi - 110002
Central
DELHI 		 9718599215

docsiddharth1@gmail.com 
Jayanta Samanta   PGIMER, Chandigarh  PGIMER Sector-12, Chandigarh
Chandigarh
CHANDIGARH 		 9855319529

dj_samanta@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institute Ethics Committte, All India Institute of Medical Sciences, New Delhi  Approved 
Institutional Ethics Committee, Asian Institute of Gastroenterology, Hyderabad  Approved 
Institutional Ethics Committee, Maulana Azad Medical College and Associated Hospital, New Delhi  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  Endoscopic ultrasound guided choledochoduodenostomy (EUS-CDS)  After informed consent, patients will be taken up for EUS-guided choledochoduodenostomy. Pre-operative biliary drainage will be carried out using EUS-guided drainage by performing choledochoduodenostomy in this arm. The procedure will be performed under moderate sedation or GA and after antibiotic prophylaxis. A therapeutic linear echoendoscope will be used and the biliary anatomy will be assessed. Biliary access will be gained from the bulb of duodenum and the cautery enhanced LAMS will be placed using a free-hand approach or over-the-guidewire method. Preferably a cautery enhanced LAMS will be used. In the case of narrow bile duct diameter precluding safe deployment of the LAMS, a partially covered tubular stent will be placed. The distal flange of either stent will be deployed under EUS guidance. The proximal flange will be deployed under endoscopic or EUS guidance. The patients will be followed up as per the schedule of the protocol.  
Comparator Agent  ERCP with biliary SEMS   After informed consent, patients will be taken up for ERCP. Pre-operative biliary drainage will be carried out using ERCP drainage by placement of SEMS in this arm. The procedure will be performed under moderate sedation or GA and after antibiotic prophylaxis. A therapeutic duodenoscope will be used and biliary cannulation will be performed using standard sphincterotome and guidewire. Once the biliary access has been achieved, cholangiogram will be taken and the stricture length delineated. Following this, a limited sphincterotomy will be performed. A Self expanding fully covered metal stent will be placed and ensured to leave at least 2 cm away from the hilum. The stent would be placed across the papilla with distal end in the duodenal lumen after deployment. The patients will be followed up as per the schedule of the protocol.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  distal malignant biliary obstruction
resectable or borderline resectable malignancy
naive case with no prior endoscopic/radiological/surgical biliary obstruction
Both, EUS-CDS and ERCP can be performed (able to reach papilla)
Indications for pre-operative biliary drainage (any one indication to be present at the time of randomization): hyperbilirubinemia; prior neoadjuvant therapy; intractable pruritis; cholangitis; multidisciplinary team decision for optimization of patient before surgery
informed consent by patient or legally acceptable representative or impartial witness as applicable 
 
ExclusionCriteria 
Details  hilar malignant biliary obstruction
benign causes of biliary obstruction
altered GI anatomy
unstable clinical conditions
pregnancy
prior sphincterotomy or biliary stent placement
uncorrectable coagulopathy or thrombocytopenia 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Composite outcome of need for biliary re-intervention and/or post-endoscopic adverse events   At 6 months  
 
Secondary Outcome  
Outcome  TimePoints 
a) Adverse event rates post-curative surgical resection
b) Technical success of the index endoscopic drainage procedure
c) Technical success of surgical intervention
d) Duration of hospital stay
e) R0 resection rates
f) Re-intervention for post-operative complications
g) Mortality secondary to the index endoscopic procedure 		 At 6 months 
 
Target Sample Size   Total Sample Size="192"
Sample Size from India="192" 
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)   01/01/2025 
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="3"
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 31-12-2028 and end date provided 31-12-2030?
    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  

Malignant distal biliary obstruction (MDBO) is a very common presentation among cases presenting with obstructive jaundice. But majority of the cases present in unresectable condition and surgery is possible only in a small precious cohort of 15-20%. For those cases undergoing surgery, pre-operative high bilirubin is a bad prognostic outcome. Among the choices of drainage, endoscopic therapy is preferred over percutaneous catheter drainage and among the stents used, fully covered self-expandable metal stents (SEMS) has shown to be superior to plastic stents owing to lower reintervention rates and higher patency. There are 2 strategies which can be adopted for biliary drainage: ERCP (endoscopic retrograde cholangiopancreatography) with biliary SEMS placement and EUS-CDS (endoscopic ultrasound guided choledochoduodenostomy) using LAMS (lumen apposing metal stent). This study has been planned as a multi-centre randomized controlled trial (RCT) to compare the 2 approaches (ERCP vs EUS-CDS) in patients with distal resectable and borderline resectable malignant biliary obstruction, as a primary drainage modality for pre-operative biliary drainage. It is a multi-centre RCT to be conducted at 4 academic tertiary care high volume centres. 


 
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