UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035296 |
|---|---|
| Receipt number | R000040214 |
| Scientific Title | Outcome of post esophageal variceal band ligation with Sucralfate plus Proton pump inhibitor vs. Proton pump inhibitor alone in cirrhotic patients |
| Date of disclosure of the study information | 2018/12/30 |
| Last modified on | 2019/03/17 00:16:09 |
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Basic information
Public title
Outcome of post esophageal variceal band ligation with Sucralfate plus Proton pump inhibitor vs. Proton pump inhibitor alone
in cirrhotic patients
Acronym
Outcome of post esophageal variceal band ligation with Sucralfate plus Proton pump inhibitor vs. Proton pump inhibitor alone
in cirrhotic patients
Scientific Title
Outcome of post esophageal variceal band ligation with Sucralfate plus Proton pump inhibitor vs. Proton pump inhibitor alone
in cirrhotic patients
Scientific Title:Acronym
Outcome of post esophageal variceal band ligation with Sucralfate plus Proton pump inhibitor vs. Proton pump inhibitor alone
in cirrhotic patients
Region
| Asia(except Japan) |
Condition
Condition
Portal hyperternsion related UGI bleeding
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of proton pump inhibitor plus sucralfate vs proton pump inhibitor alone in EVL ulcers outcome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To compare the outcomes of variceal band ligations in patients receiving Sucralfate plus PPI vs PPI alone.
Key secondary outcomes
1) To find out the incidence of EVL ulcers in both the groups.
2) To find out the number and mean size of EVL in both the groups within two weeks.
3) To find out the incidence of EVL bleeding or death due to any cause within two weeks of the procedure.
4) To find out the effect of Child-Pugh score and incidence of ulcer formation in both the groups.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
After variceal band ligation, Patient in PPI and sucralfate group will be given Tab Pantoprazole 40 mg twice daily for 14 days along with syrup Sucralfate 10ml four times daily for next two weeks.
Interventions/Control_2
After variceal band ligation, patient in PPI will be given only Tab Pantoprazole 40 mg twice daily only for 14 days
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients with chronic liver disease who undergo esophageal variceal banding
Key exclusion criteria
1. Patients presenting with fundal varices.
2. Patients who had been subjected to injection sclerotherapy sessions or having endoscopically confirmed pre-existing oesophageal ulcers.
3. Patients with co- morbidities like diabetes, bleeding disorders, heart failure, chronic kidney disease and malignancy
Target sample size
58
Research contact person
Name of lead principal investigator
| 1st name | Binod |
| Middle name | |
| Last name | Karki |
Organization
Bir Hospital, National Academy of Medical Sciences
Division name
Gastroenterology
Zip code
44600
Address
Mahabaudhha, Kathmandu, Nepal.
TEL
009779851152447
binodkarki@yahoo.com
Public contact
Name of contact person
| 1st name | Binod |
| Middle name | |
| Last name | Karki |
Organization
Bir Hospital National Academy of Medical sciences
Division name
Gastroenterology
Zip code
44600
Address
Mahabaudhha, Kathmandu, Nepal.
TEL
009779851152447
Homepage URL
http://www.nams.org.np
binodkarki@yahoo.com
Sponsor or person
Institute
Bir Hospital National Academy of Medical sciences
Institute
Department
Personal name
Funding Source
Organization
Bir Hospital National Academy of Medical science
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Nepalese
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Academy of Medical Sciences
Address
Bir Hospital, Mahabaudhha, Kathmandu
Tel
+977-1-4230710
admin@nams.org.np
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
58
Results
Post EBL ulcer formation is universal phenomenon and using additional sucralfate in a patient who is already taking PPI may not be more effective in reducing the number and size of ulcers and just add to the cost of therapy. Low albumin is the predictor of multiple ulcer formation after esophageal band ligation.
Results date posted
| 2019 | Year | 03 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 01 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 18 | Day |
Last modified on
| 2019 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040214
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