| CTRI Number |
CTRI/2024/01/061478 [Registered on: 15/01/2024] Trial Registered Prospectively |
| Last Modified On: |
05/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Endoscopic ultra sonography guided thrombin with glue injection in gastric varices |
|
Scientific Title of Study
|
To compare the efficacy and safety of EUS guided combined application of thrombin and cyanoacrylate injection with EUS guided cyanoacrylate injection alone for the management of patients with gastroesophageal varices: A randomized control 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 |
Dr Prachis ashdhir |
| Designation |
Associate Professor |
| Affiliation |
SMS medical college Jaipur |
| Address |
Department of Gastroenterology Room No. 313, 3rd Floor SMS
Super specialty Hospital, Jaipur Jaipur RAJASTHAN 302004 India
Jaipur
Rajasthan
302004
India
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829966420 |
| Fax |
|
| Email |
pa894@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prachis ashdhir |
| Designation |
Associate Professor |
| Affiliation |
SMS medical college Jaipur |
| Address |
Department of Gastroenterology Room No. 313, 3rd Floor SMS
Super specialty Hospital, Jaipur Jaipur RAJASTHAN 302004 India
Jaipur
Rajasthan
302004
India
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829966420 |
| Fax |
|
| Email |
pa894@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Narendra Kumar Bishnoi |
| Designation |
Senior Resident |
| Affiliation |
SMS medical college Jaipur |
| Address |
Department of Gastroenterology Room No. 313, 3rd Floor SMS
Super specialty Hospital, Jaipur Jaipur RAJASTHAN 302004 India
Jaipur
Rajasthan
302004
India
Jaipur
RAJASTHAN
302004
India |
| Phone |
9702234327 |
| Fax |
|
| Email |
bishnoimbbs17@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMS medical college & hospital, Jaipur Rajasthan |
|
|
Primary Sponsor
|
| Name |
MMCSBY Scheme Govt of Rajasthan |
| Address |
Department of Gastroenterology Room No. 313, 3rd Floor, SMS
Super specialty Hospital, Jaipur |
| 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 Prachis ashdhir |
SMS Medical College Jaipur |
Department of
Gastroenterology,
Room No. 313, 3rd
Floor, SMS
Super specialty
Hospital, Jaipur
Rajasthan
Jaipur
RAJASTHAN |
9829966420
pa894@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| office of ethics committee SMS medical college Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K318||Other specified diseases of stomach and duodenum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
cyanoacrylate glue |
Patients will be randomly
allocated in a 1:1 manner to
either EUS-guided thrombin with cyanoacrylate injection OR EUS guided
cyanoacrylate injection alone for
the management of gastric
varices types GOV2 and IGV1.
32 patients with gastric varices
who will be managed with EUS
guided cyanoacrylate injection, over a period of one year of study duration. |
| Intervention |
Thrombin plus cyanoacrylate glue |
Patients will be randomly allocated in a 1:1 manner to either EUS-guided thrombin with cyanoacrylate injection OR EUS guided cyanoacrylate injection alone for the management of gastric varices types GOV2 and IGV1. 32 patients with gastric varices who will be managed with EUS guided thrombin with cyanoacrylate injection, over a period of one year of study duration. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group- ≥18
2. Patients diagnosed with gastric varices type GOV2 or IGV1 according to the Sarin classification
3. Treated for active bleed or secondary prophylaxis |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Technical success- defined as completion of the intended procedure
2. Clinical success- defined as complete and immediate obliteration of the varix,
evaluated via esophagogastroduodenoscopy (EGD) and the absence of flow during
EUS Doppler evaluation |
Follow-up EGD and an EUS Doppler evaluation will be performed at 1st month 3rd month, 6th month and 12th month after the initial procedure. The reappearance of gastric varices, need for reintervention, survival and adverse events will be evaluated.
Patients will be followed upto 12th months after enrollment or until the date of death via visits to the SMS hospital and review of medical, EGD, and EUS records. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Reappearance of gastric varices during follow-up
2. Rebleeding, the need for reintervention
3. The complication & survival rates |
Follow-up EGD & an EUS Doppler evaluation will be performed at 1st month 3rd month, 6th month & 12th month after the initial procedure. The reappearance of gastric varices, need for reintervention, survival & adverse events will be evaluated.
Patients will be followed upto 12th months after enrollment or until the date of death via visits to the SMS hospital & review of medical, EGD, & EUS records. |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 4 |
|
Date of First Enrollment (India)
|
20/01/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bishnoimbbs17@gmail.com].
- For how long will this data be available start date provided 20-08-2023 and end date provided 30-03-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Acute gastric variceal haemorrhage is a catastrophic complication of portal hypertension and prevalence of gastric varices in patients with portal hypertension is reported to be about 25%. It commonly presents with hematemesis and/or melena.
Bleeding from gastric varices is more severe and life-threatening than bleeding from oesophageal varices and is associated with high mortality, morbidity rates and medical care cost and it needs urgent effective and safe treatment modalities to prevent morbidity and mortality
The purpose of this study is to statistically compare the efficacy and safety of EUS-guided combined applications of thrombin and cyanoacrylate injection with EUS-guided cyanoacrylate injection alone for the management of patients with gastroesophageal varices type II (GOV II) and isolated gastric varices type I (IGV I) in a prospective randomized controlled trial. |