UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000035296
Receipt No. 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 (Ver. 5)

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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
Last 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
Email binodkarki@yahoo.com

Public contact
1st 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
Email binodkarki@yahoo.com

Sponsor
Institute Bir Hospital National Academy of Medical sciences
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040214