| CTRI Number |
CTRI/2025/08/092442 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Testing the Effectiveness of Sucralfate in Preventing Ulcers After Endoscopic Treatment for Bleeding Esophageal Varices: A Randomized Clinical Trial |
|
Scientific Title of Study
|
Randomized Clinical Trial to study efficacy of adding on Sucralfate for prevention of post endoscopic variceal
ligation (EVL) ulcer in patients with variceal bleeding |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vijay Alexander |
| Designation |
Asst. Professor, Hepatology |
| Affiliation |
Christian Medical College Hospital |
| Address |
Department of Hepatology,
A block, 7th Floor, Christian Medical College Hospital,
Ranipet Campus
Vellore
TAMIL NADU
632004
India |
| Phone |
9645431265 |
| Fax |
|
| Email |
vijayalexander@cmcvellore.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijay Alexander |
| Designation |
Asst. Professor, Hepatology |
| Affiliation |
Christian Medical College Hospital |
| Address |
Department of Hepatology,
A block, 7th Floor, Christian Medical College Hospital,
Ranipet Campus
TAMIL NADU
632004
India |
| Phone |
9645431265 |
| Fax |
|
| Email |
vijayalexander@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Vijay Alexander |
| Designation |
Asst. Professor, Hepatology |
| Affiliation |
Christian Medical College Hospital |
| Address |
Department of Hepatology,
A block, 7th Floor, Christian Medical College Hospital,
Ranipet Campus
TAMIL NADU
632004
India |
| Phone |
9645431265 |
| Fax |
|
| Email |
vijayalexander@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Internal Fluid Research Grant, Christian Medical College, Vellore - 632004, Tamil Nadu State, India |
|
|
Primary Sponsor
|
| Name |
Internal Fluid Research Grant CMC Vellore |
| Address |
Christian Medical College, Vellore - 632004, Tamil Nadu State, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vijay Alexander |
Christian Medical College, Vellore |
Department of Hepatology, A Block 7th Floor, Christian Medical College, Ranipet Campus - 632004, Tamil Nadu State, India
Vellore
TAMIL NADU |
09645431265
vijayalexander@cmcvellore.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board (IRB), CMC Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K77||Liver disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
High Dose Pantoprazole alone |
Tab. Pantoprazole 40mg twice daily x 21 days post EVL |
| Intervention |
Sucralfate + High dose Pantoprazole |
Syp. Sucralfate 1g thrice daily + Tab. Pantoprazole 40mg twice daily x 21 days post EVL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Consecutive subjects presenting for elective / emergency variceal band ligation will be considered eligible for inclusion in the study. Inclusion criteria are subjects with portal hypertension and varices between the ages of 18 and 80 years who has had a history of prior variceal hemorrhage. Patients undergoing secondary EVL will only be recruited. |
|
| ExclusionCriteria |
| Details |
The exclusion criteria for the study include patients with hepatocellular carcinoma (HCC) with portal vein thrombosis (PVT), acute PVT, or intolerance to non-selective beta-blockers; those using anticoagulation or antiplatelet drugs; pregnant individuals or patients under 18 years of age; and those undergoing ongoing therapy with anti-acid agents or with a history of allergy or adverse reactions to proton pump inhibitors and/or sucralfate. Additionally, patients with pre-existing esophageal ulcers, a history of surgical anti-reflux procedures (e.g., Nissen, Belsey, or Toupet), or Barrett’s esophagus are excluded, as are those undergoing primary endoscopic variceal ligation (EVL) or with a history of liver transplantation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Objective
1. The number of esophageal ulcers identified at follow-up endoscopy
2. The size of esophageal ulcers identified at follow-up endoscopy after EVL
|
Primary Objective
1. The number of esophageal ulcers identified at follow-up endoscopy
2. The size of esophageal ulcers identified at follow-up endoscopy after EVL
Secondary Objective:
1. Incidence of post-EVL ulcer bleed
2. Delta hemoglobin after 21 days from the last scopy
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Objective:
1. Incidence of post-EVL ulcer bleed
2. Delta hemoglobin after 21 days from the last scopy
|
14 - 21 days post EVL |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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 3 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="2"
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 - NO
|
|
Brief Summary
|
Esophageal variceal ligation (EVL) is performed to
control variceal hemorrhage. Side effects of EVL include hemorrhage, chest
pain, dysphagia, and odynophagia. Because gastric acid may exacerbate post-banding
ulcers and delay healing, Sucralfate may decrease the side effects associated
with EVL.
This study aims to assess the efficacy of Sucralfate
as an adjunct to elective / emergency EVL.
We plan to perform an open-label randomized controlled
trial of Sucralfate after EVL. Subjects in the sucralfate arm will receive 1g
Sucralfate suspension (10ml) three times a day and 40mg of twice daily
pantoprazole for 21 days. Control subjects will receive only oral pantoprazole
40mg twice daily for 21 days.
All subjects will undergo upper GI endoscopy 14 – 21 days
after banding or if they present with a bleed episode earlier than the
stipulated time.
At follow-up endoscopy, the mean number of ulcers and
the ulcer dimensions will be measured and compared.
|