FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/077586 [Registered on: 03/12/2024] Trial Registered Prospectively
Last Modified On: 02/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Endoscopic ]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare the two techniques to drain the biliary system in patients having biliary tree obstruction at the hilum, viz, radiological method using percutaneous technique and endoscopic ultrasound guided stent placement  
Scientific Title of Study   Comparison of percutaneous transhepatic biliary drainage (PTBD) versus endoscopic ultrasonography (EUS) guided hepaticogastrostomy (HGS) in malignant hilar biliary obstruction: a randomized controlled 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  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  Marikanty Adarsh  
Designation  Senior Resident  
Affiliation  Postgraduate Institute of Medical Education and Research, Chandigarh 
Address  Department of Gastroenterology, PGIMER, Chandigarh Sector-12

Chandigarh
CHANDIGARH
160012
India 
Phone  996899333  
Fax    
Email  marikanty.adarsh@gmail.com  
 
Source of Monetary or Material Support  
Department of Gastroenterology, 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 = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
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 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
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-guided HGS  After informed consent and randomization, the patient will be subjected to EUS-guided hepaticogastrostomy (EUS-HGS) in this arm. The procedure will be performed under moderate sedation or general anesthesia. Pre-procedure antibiotic prophylaxis will be administered. A therapeutic echoendoscope will be positioned in the stomach and the III hepatic segment will be identified. Intrahepatic access to the dilated ducts will be achieved by transgastric puncture, using a 19-gauge needle. After access to the biliary tree has been confirmed by aspiration of bile, a 0.025/35inch guidewire will be advanced into the common bile duct or right hepatic duct. A 6-Fr cystotome using monopolar current in Autocut mode will be subsequently advanced through the gastric wall, into the dilated segmental duct under fluoroscopic guidance and EUS. Finally, partially covered self-expandable metal stent (SEMS) hybrid stent will be deployed, creating a hepaticogastrostomy, with the distal flange in the biliary system and the proximal part in the lumen of the stomach. The position of the stent will be confirmed endoscopically and on fluoroscopy. The clinical success will be defined at 1 month. The patients will be followed up as per the study protocol for other outcomes for 6 months.  
Comparator Agent  PTBD  After informed consent and randomization, the patient will be subjected to percutaneous transhepatic biliary drainage (PTBD)in this arm The procedures will be performed in an angio-suite after local anesthesia as well as analgesia. Pre-procedure antibiotic prophylaxis will be administered. Before the intervention, liver sonography will be performed to plan the procedure. Only left sided PTBD will be attempted. A peripheral branch of the bile ducts will be punctured with a 18G needle under sonography and fluoroscopy guidance. In case of nondilated bile ducts, the punctures will be performed close to the peripheral branches of the portal vein. The core needle will then be removed, and a mixture of NaCl solution and iodine contrast will be carefully injected while withdrawing the needle until bile ducts were visible. In case of difficult puncture, if a central duct was punctured first, the needle will be left in place and contrast medium injected to opacify the peripheral ducts, which were then punctured using a second needle. In case of successful puncture, a 0.018″ nitinol guidewire will be inserted and thereafter a 4F introducer sheath will be introduced using the Seldinger technique. Thereafter, a 0.035″ guidewire will be advanced in the small bowel. If necessary, a 4F hydrophilic catheter (different shapes) will be used to guide the wire. Thereafter, the wire will be exchanged to a stiff 0.035″ guidewire and a 8F internal external drainage will be placed. The clinical success will be defined at 1 month. The patients will be followed up as per the study protocol for other outcomes for 6 months.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  malignant hilar biliary obstruction with type I and II block requiring biliary drainage
Failed or non-feasible ERCP cases
informed consent  
 
ExclusionCriteria 
Details  Malignant Hilar obstruction with type IIIa, IIIb and IV block
benign cause of biliary obstruction
atrophied left lobe
unfit for endoscopic procedure
Non-correctable coagulopathy, thrombocytopenia
pregnant female 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Rate of clinical success between the two arms of EUS-HGS and PTBD  at 1 month post procedure  
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare technical success between both the groups
2. Re-intervention rates between both the groups
3. Procedure related adverse events as per ASGE- Lexicon guidelines between the two groups
4. Surgical outcomes and their complications between both the groups
5. Hospital and ICU stay
6. Quality of life assessment
7. Any additional intervention on follow up due to recurrent biliary obstruction
 		 6 months  
 
Target Sample Size   Total Sample Size="95"
Sample Size from India="95" 
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 01-12-2030?
    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   The primary treatment of jaundice secondary to a malignancy hilar biliary obstruction (MHBO) is stenting during endoscopic retrograde cholangiopancreatography. However, ERCP can fail or sometimes not feasible due to duodenal obstruction or  difficulty in passing guidewire across the stricture. In such cases, percutaneous transhepatic biliary drainage (PTBD) is most commonly performed for decades and is recommended second line in most guidelines.  EUS guided biliary drainage procedures have been recognized as an appealing alternative to PTBD. Amongst them, EUS Hepaticogastrostomy (HGS) is the only technically possible method available for MHBO. Both EU-HGS and PTBD are technically available alternatives in MHBO cases with failed ERCP. But in literature, there are only retrospective studies with heterogenous cohort. Hence, we plan to conduct a prospective randomized study with a homogenous cohort comparing the outcomes between EUS guided hepaticogastrostomy and PTBD, as a second line management for biliary drainage in MHBO cases with failed primary ERCP.  
Close