| CTRI Number |
CTRI/2026/04/108065 [Registered on: 09/04/2026] Trial Registered Prospectively |
| Last Modified On: |
08/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Comparing two different stent types during endoscopic ultrasound guided hepatico-gastrostomy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of fully covered and partially covered metal stent for endoscopic ultrasound guided hepatic-gastrostomy on patients with un-resectable malignancy to explore stent patency rates |
|
Scientific Title of Study
|
Partially covered vs Fully covered metal stent for endoscopic ultrasound guided hepatico-enterostomy: A randomized control trial |
| Trial Acronym |
COVER-HGS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jimil Shah |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Department of Gastroenterology
Nehru Hospital
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8655376773 |
| Fax |
|
| Email |
shahjimil22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jimil Shah |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Department of Gastroenterology
Nehru Hospital
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8655376773 |
| Fax |
|
| Email |
shahjimil22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jimil Shah |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Department of Gastroenterology
Nehru Hospital
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8655376773 |
| Fax |
|
| Email |
shahjimil22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research (PGIMER) as providing Infrastructure support |
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
Not applicable |
| Type of Sponsor |
Other [Not applicable] |
|
|
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 |
| Jimil Shah |
Postgraudte Institute of Medical Education and Research |
Department of Gastroenterology, Nehru Hospital
Chandigarh
CHANDIGARH |
08655376773
shahjimil22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Fully covered self expanding metal stent (FC-SEMS) |
Patients with unresectable maliganacy with biliary obstruction, fulfilling inclusion criteria will be taken up EUS guided hepatico-gastrstomy. After successfully, seceuring guidewire in intrahepatic biliary ducts from stomach, FC-SEMS will be used to complete the EUS-HGS. After successful procedure, the patients will be kept on close follow-up till 12 months to check for stent patency. |
| Comparator Agent |
Partially covered self-expanding metal stent (PC-SEMS) |
Patients with unresectable maliganacy with biliary obstruction, fulfilling inclusion criteria will be taken up EUS guided hepatico-gastrstomy. After successfully, seceuring guidewire in intrahepatic biliary ducts from stomach, PC-SEMS will be used to complete the EUS-HGS. After successful procedure, the patients will be kept on close follow-up till 12 months to check for stent patency. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with histologically confirmed malignant biliary obstruction
2. Patients with unresectable or locally advanced malignancy
3. Patients in whom ERCP has failed or not feasible |
|
| ExclusionCriteria |
| Details |
1. Patients with prior biliary ductal plastic or metal stent placement
2. Patients in whom intrahepatic biliary radicles are not dilated
3. Patients with poor (more than ECOG 3) performance status
4. Patients with hilar involvement (less than 2cm from hilum)
5. Patients with uncorrectable coagulopathy
6. Patients with multiple intra-hepatic metastasis (more than 30% of liver parenchyma)
7. Patients who refuse to participate in the trial
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of stent dysfunction (due to migration or stent blockage) requiring re-intervention |
Till mortality or 12 months follow-up whichever is earlier |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Clinical success across both the groups |
Till mortality or 12 months follow-up whichever is earlier |
| 2. Procedure related adverse events across both the groups |
Till mortality or 12 months follow-up whichever is earlier |
| 3. Time for recurrent biliary obstruction |
Till mortality or 12 months follow-up whichever is earlier |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
20/04/2026 |
| 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="6"
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
|
Biliary obstruction remains one of the most cause for increasing morbidity in patients with carcinoma pancreas, carcinoma gall bladder, cholangiocarcinoma or peri-ampullary carcinoma. Various methods including endoscopic retrograde cholangio-pancreatography (ERCP), endoscopic ultrasound guided biliary drainage (EUS-BD), percutaneous transhepatic biliary drainage (PTBD) etc. can be used. Though traditionally, ERCP was used as a first line modality for drainage of obstructed biliary system, in around 15% to 20% of patients, ERCP attempt gets failed either due to concurrent gastric outlet obstruction or due to difficult biliary canulation. In recent times, EUS guided biliary drainage has emerged as a feasible option in this difficult cases. In a recent meta-analysis, it has shown to be associated with better clinical success (OR, .45; 95% CI, .23-.89; I2 = 0%), fewer postprocedure adverse events (OR, .23; 95% CI, .12-.47; I2 = 57%), and lower rate of reintervention (OR, .13; 95% CI, .07-.24; I2 = 0%) compared to PTBD. Amongst EUS guided biliary drainage, EUS guided hepatico-gastrostomy is feasible even in hilar block as well as in presence of gastric outlet obstruction along with lower rates of stent dysfunction compared to EUS guided choledochoduodenostomy. Technique of EUS guided hepatico-gastrostomy has also undergone more standardised in last decade with better clinical outcomes and lower adverse event rates. Regarding stent selection, dedicated partially covered stent was developed to prevent the blockage of side branches of the biliary ducts. However, the uncovered portion is associated with risk of tissue hyperplasia, stent block by biliary stasis or by food obstruction. Despite initial retrospective studies has shown reduction in risk of segmental cholangitis, risk of recurrent stent obstruction remains high. Recently, Cho S H et al., did a propensity matched analysis of two different types of stent which are being used in EUS guided hepatico-gastrostomy. In that study, patients in whom fully covered stent was used had higher stent patency (76%) compared to patients in whom partially covered metal stent (43%) was used (p=0.03). Moreover, patients in fully covered group required less re-interventions compared to patients in partially covered group (20% vs 38%; p=0.084).(7) However, in absence of any dedicated prospective study, we are planning to perform a randomized controlled trial comparing fully covered vs partially covered metal stent in patients undergoing EUS guided hepatico-gastrostomy.
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