| CTRI Number |
CTRI/2022/10/046363 [Registered on: 11/10/2022] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess the Comparison between Endoscopic Ultrasound-Guided Coil and n-butyl cyanoacrylate glue versus radiological intervention in preventing rebleeding in patients with gastric varices |
|
Scientific Title of Study
|
Secondary prophylaxis of gastric variceal bleed: Endoscopic Ultrasound-Guided Coil and n-butyl cyanoacrylate glue versus radiological intervention: A Randomized Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepak Gunjan |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No.3111, 3rd floor, Teaching Block,
Department of Gastroenterology, AIIMS,Ansari Nagar
South West
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
deepakgunjan31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Gunjan |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No.3111, 3rd floor, Teaching Block,
Department of Gastroenterology, AIIMS,Ansari Nagar
South West
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
deepakgunjan31@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Gunjan |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No.3111, 3rd floor, Teaching Block,
Department of Gastroenterology, AIIMS,Ansari Nagar
South West
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
deepakgunjan31@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Department of Gastroenterology, All India institute of Medical Sciences |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepak Gunjan |
All India Institute of Medical Sciences |
Department of Gastroenterology and Human Nutrition Unit
South West
DELHI |
9811225431
deepakgunjan31@gmail.com |
| Dr Arun Valsan |
Amrita Institute of Medical Sciences |
DIVISION OF HEPATOLOGY
Ernakulam
KERALA |
8411051156
drarunvalsan@gmail.com |
| Dr Ashisha janeela M |
Christian Medical College |
division of Hepatology
Vellore
TAMIL NADU |
9940736797
asisha.jane@gmail.com |
| Dr siddharth srivastava |
Dr siddharth srivastava |
GB pant institute of medical education and research
Central
DELHI |
9968327209
docsiddharth1@gmail.com |
| Dr Rajesh puri |
Medanta -The Medicity Gurgaon |
The Medicity Gurgaon,Haryana
Gurgaon
HARYANA |
9811638338
purirajesh1969@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee of Amrita School of Medicine |
Approved |
| Institute Ethics Committee |
Approved |
| Institute Ethics Committee Medanta |
Approved |
| IRB office of Research Christian medical college |
Approved |
| Maulana Azad Medical college and Associated Hospital Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EUS guided coil embolization and n-butyl cyanoacrylate glue |
Under the EUS guidance, gastric varices will be localized and its afferent pathway will be identified in Doppler study. After identification of GV, it will be punctured with 19G EUS needle and stylet will be removed followed by aspiration of blood for confirmation of puncture of GV. After puncturing, metal coils with fibres (Nester Embolization Coils, Wilson & Cook) will be pushed by the stylet into the GV lumen. Multiple coils will be pushed till the complete obliteration of GV under EUS guidance. Doppler will be applied to look for the residual varices and 1 mL glue will be injected to complete the obliteration of the GVs. Metal coils with fibre are made up of platinum and are available in various sizes. The size of the first coil will be 20% larger than the GV size. The usual size of the coils will be MWCE-35-14-6 to MWCE-35-14-12. |
| Comparator Agent |
Radiological intervention |
CT portography of these patients will then be reviewed for the presence of shunts amenable for BRTO. In the presence of an amenable shunt, the patient will be allotted to the BRTO arm. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Cirrhosis with acute variceal bleeding
2. GOV2 and IGV1
3. Age between 18-65 years
4. Willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Variceal bleeding secondary to causes other than cirrhosis
2. Variceal bleeding from EV
3. Patients with malignancy/disseminated intravascular coagulation (DIC)/known coagulopathic disorder (hemophilia) apart from cirrhosis.
4. History of intake of platelets inhibitors (e.g., aspirin, clopidogrel) and drugs affecting coagulation cascade (e.g., vitamin K antagonists) within past 7 days
5. Pregnant women
6. History of underlying hypercoagulable/ hypocoagulable states e.g. paroxysmal nocturnal hemoglobinuria (PNH), and polycythemia vera.
7. Patients with refractory shock
8. Sepsis/ACLF
9. Contraindication to endoscopy
10. Not willing to provide consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| 1. To compare the rebleed rate between the EUS-guided coil embolization and glue injection with endoscopic cyanoacrylate glue injection and BRTO at 1 year |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. All-cause mortality at 1 year
2. Grade of esophageal varices at 1, 3, 6, and 12 months
3. Complications and adverse events at 1, 3, 6, and 12 months
|
1. 1 Year
2. 1,2,3,6, and 12 months
3. 1,2,3,6, and 12 months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="118"
Sample Size from India="118"
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)
|
17/10/2022 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Portal
hypertension (PHT) is a major consequence of cirrhosis and is responsible for
its most severe complications leading to increased morbidity and mortality,
including bleeding from gastroesophageal varices. The most common cause of
bleeding in cirrhosis is bleeding from esophageal varices (EVs), followed by
gastric varices (GVs). GVs are less
common (20%) and have a lower bleeding risk. Compared to EVs bleeding, GV
bleeding is massive, requires more blood transfusions, and has higher
mortality.
The
1-year risk of GV bleeding is 10%–16%[2–5]. The cumulative risk for
GV hemorrhage at 1, 3, and 5 years is 16%, 36%, and 44%, respectively. In contrast to EVs, GVs bleed
at lower portal pressure and do not correlate with hepatic venous pressure gradient
(HVPG). Due to this, medical therapy for
lowering portal pressure is not beneficial in managing GV. The treatment of GVs is not
well standardized compared to EVs, where the primary prophylaxis, secondary
prophylaxis, and treatment are well established. The most common and easily available treatment
of GV is n-butyl cyanoacrylate glue injection. The risk of rebleed and
mortality after glue therapy is 15% and 3% in a randomized control trial during
a median follow-up of 26 months, respectively. Complications due to glue injection include
embolization of the glue thrombus, exacerbation of bleeding, and impaction of
the needle into the GV, portal vein thrombosis, and infection. The most feared complication is glue pulmonary
embolism; however, the largest series documented that the clinically significant
systemic embolic events rate was 0.7%. Other complications are very rare. It
is clear that if GV rebleed, treatment options are BRTO, TIPSS and EUS-guided
coil embolization, but which one is better is not clear. Therefore in this RCT,
we will compare the efficacy and safety of EUS-guided coil embolization with
glue injection and balloon-occluded retrograde transvenous obliteration (BRTO)
to prevent rebleeding in patients with cirrhosis and GVs after primary
hemostasis.
|