| CTRI Number |
CTRI/2023/06/054442 [Registered on: 26/06/2023] Trial Registered Prospectively |
| Last Modified On: |
31/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to evaluate the role of acid suppression medication in reducing post banding ulcers and re bleeding after ligation of bleeding oesophageal varices (dilated blood vessels) in patients with liver cirrhosis |
|
Scientific Title of Study
|
A randomized controlled trial to study the effect of PPI vs No-PPI after EVL on recurrent bleeding episodes in patients of liver cirrhosis with acute 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 |
Abhishek Yadav |
| Designation |
Senior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Room number 11, department of Gastroenterology, ground floor, F block, Nehru Hospital, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8769470048 |
| Fax |
|
| Email |
abhishekyadav1992@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Harshal Mandavdhare |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Room number 11, department of Gastroenterology, ground floor, F block, Nehru hospital, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9592814877 |
| Fax |
|
| Email |
hmandavdhare760@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Harshal Mandavdhare |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Room number 11, department of Gastroenterology, ground floor, F block, Nehru hospital, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
hmandavdhare760@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Gastroenterology, ground floor, F block, Nehru hospital, Sector 12, Chandigarh |
| 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 |
| Harshal Mandavdhare |
Post Graduate Institute of Medical Education and Research |
Room number 11, department of Gastroenterology, ground floor, F block, Nehru hospital, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh
Chandigarh
CHANDIGARH |
9592814877
hmandavdhare760@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post Graduate Institute of Medical Education and Research, Chandigarh, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K740||Hepatic fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No proton pump inhibitor would be used after achieving hemostasis by EVL in patients with bleeding esophageal varices |
After achieving hemostasis by EVL for bleeding esophageal varices, patients in no PPI group would receive only standard treatment to reduce portal hypertension i.e. beta blocker Tab Carvedilol 3.125mg once a day for next 3 months after index EVL procedure |
| Intervention |
Proton pump inhibitor (PPI) after achieving hemostasis by EVL of bleeding esophageal varices |
After achieving hemostasis by EVL for bleeding esophageal varices, patients in PPI group would receive Tab Esomeprazole 40 mg once a day in addition to standard treatment to reduce portal hypertension i.e. beta blocker Tab Carvedilol 3.125mg once a day for next 3 months after index EVL procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of liver cirrhosis presenting with decompensation in the form of first episode of variceal bleed |
|
| ExclusionCriteria |
| Details |
1-Refractory bleed requiring TIPSS or emergency surgery apart from EVL
2-Upper GI bleed due to acid peptic disease/GERD
3-Hepatocellular carcinoma
4-upper GI Bleed due to malignant tutors go the GI tract
5-Hemodynamic instability requiring vasopressor support
6-Hepatic encephalopathy grade III or above
7-History of surgery of oesophagus, stomach or liver
8- Renal failure with creatinine>2mg/dl
9-Presence of gastric varices as source of upper GI bleed
10-Pregnancy/breastfeeding
11-PPI allergy
12-Mising informed consent |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the rate of recurrent bleeding between PPI versus no PPI groups after EVL in liver cirrhosis patients with acute varicella bleed |
From baseline till 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1-Compare mortality between the 2 groups
2-Compare the size & number of post EVL ulcers at 2 weeks after first EVL session
3- Compare chest pain between 2 group at 2 week and 12 weeks
4-Compare rate of dysphagia between the 2 groups |
At 3 months |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
Final Enrollment numbers achieved (Total)= "170"
Final Enrollment numbers achieved (India)="170" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2023 |
| Date of Study Completion (India) |
05/04/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [hmandavdhare760@gmail.com].
- For how long will this data be available start date provided 30-11-2024 and end date provided 30-11-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NA
|
|
Brief Summary
|
Proton Pump Inhibitors (PPI) are extensively used in many acid related disorders due to their high efficacy in inhibiting gastric acid secretion. They are also often used in cirrhosis patients with variceal or portal hypertensive gastropathic bleeding to prevent peptic complications. The prevalence of varices is around 30% in compensated and 60% in decompensated cirrhotic patients. Apart from Child-Pugh score, the size of varices is also a risk factor for variceal bleeding where medium and large esophageal varices bleed at higher rate than small esophageal varices. Endoscopic variceal band ligation (EVL) is currently recommended therapy of choice in patients with acute variceal bleeding along with vasoconstrictors. Non selective beta blockers are also used along with EVL for primary as well as secondary prophylaxis of esophageal varices. There is a constant search going on for effective non-invasive therapies in patients with variceal bleed and PPIs owing to their safety profile and efficacy in non variceal bleed are being considered a candidate for the same. The latest Baveno VII guidelines also advise to stop PPIs after endoscopic therapy unless there is clear indication to continue them, but the level of evidence for the statement is very low and strength of recommendation is weak. In this study we would aim to determine the effect of PPI on recurrent episodes of variceal bleeding after EVL in liver cirrhosis patients that would help making informed decision regarding the use of PPIs in cases with variceal bleeding. |