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Initiation of Diet in Esophageal Varices After Ligation (IDEAL) Study (IDEAL)

Primary Purpose

Liver Cirrhosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Early Diet Group
Late Diet Group
Sponsored by
Dr Cipto Mangunkusumo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Liver Cirrhosis focused on measuring Esophageal Varices After Ligation, Initiation of Diet, Liver cirrhosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Liver cirrhosis patients who underwent esophageal variceal ligation

Exclusion Criteria:

  • Hemodynamic instability (shock)
  • Possible perforation of the esophagus
  • Esophageal diverticula
  • Esophageal strictures

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Early Diet Group

    Late Diet Group

    Arm Description

    1st diet: 100 ml of clear fluid (1 hour after esophageal variceal ligation) 2nd diet: 100 ml of clear fluid (4 hours after the 1st diet) 3rd diet: soft porridge (the amount will be calculated according to patient's caloric needs) which will be given 4 hours after the 2nd diet 4th diet: soft porridge (the amount will be calculated according to patient's caloric needs) which will be given 6 hours after the 3rd diet 5th diet: porridge (the amount will be calculated according to patient's caloric needs) which will be given 6 hours after the 4th diet 6th diet: porridge (the amount will be calculated according to patient's caloric needs) which will be given 6 hours after the 5th diet 7th diet: soft rice (the amount will be calculated according to patient's caloric needs) which will be given 6 hours after the 6th diet 8th diet: regular rice (the amount will be calculated according to patient's caloric needs) which will be given 6 hours after the 7th diet

    1st diet : 100 ml of clear fluid (6 hours after esophageal variceal ligation) After the 1st diet (Day 1): 6x100 ml of clear fluid for 24 hours Day 2: soft porridge (the amount will be calculated according to patient's caloric needs) for 24 hours Day 3: porridge (the amount will be calculated according to patient's caloric needs) for 24 hours Day 4: soft rice (the amount will be calculated according to patient's caloric needs) for 24 hours Day 5: regular rice (the amount will be calculated according to patient's caloric needs) for 24 hours and beyond

    Outcomes

    Primary Outcome Measures

    Early rebleeding event after esophageal variceal ligation
    Early rebleeding event is hematemesis, melena and/or hematochezia that occurs within 5 days (120 hours) after esophageal variceal ligation

    Secondary Outcome Measures

    Late rebleeding event after esophageal variceal ligation
    Late rebleeding event is hematemesis, melena and/or hematochezia that occurs between over than 5 days until 28 days after esophageal variceal ligation

    Full Information

    First Posted
    May 6, 2021
    Last Updated
    May 14, 2021
    Sponsor
    Dr Cipto Mangunkusumo General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04890210
    Brief Title
    Initiation of Diet in Esophageal Varices After Ligation (IDEAL) Study
    Acronym
    IDEAL
    Official Title
    A Comparison of Clear Fluid Diet Initiation Time on Rebleeding Rate and Convenience Level in Liver Cirrhosis Patients Underwent Esophageal Variceal Ligation at Cipto Mangunkusumo Hospital
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 20, 2021 (Anticipated)
    Primary Completion Date
    November 1, 2021 (Anticipated)
    Study Completion Date
    December 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Dr Cipto Mangunkusumo General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Objective The purpose of this study is to evaluate whether there is a significant difference of early rebleeding rate (within the first 5 days after esophageal variceal ligation), late rebleeding rate (more than 5 days until 28 days after esophageal variceal ligation), and convenience level between cirrhotic patients in early diet group versus late diet group. Method This study is a single blind randomised clinical trial. Subjects will be selected based on inclusion and exclusion criteria, then the subjects will be randomly divided into 2 groups, the early diet group (clear fluid diet is initiated 1 hour after esophageal variceal ligation) and the late diet group (clear fluid diet is initiated 6 hours after esophageal variceal ligation). The intervention arm is the early diet group, while the control arm is the late diet group. The primary outcome is the early rebleeding rate. The secondary outcomes are late rebleeding rate and patient's convenience level which will be measured using Visual Analogue Scale (VAS). Expected result The expected result is there will be no difference in early bleeding rate, late bleeding rate, and convenience level between early diet group versus late diet group.
    Detailed Description
    This study is a single blind randomised controlled trial (RCT) that will be conducted at gastrointestinal endoscopy center division of gastroenterology, integrated procedure room division of hepatobiliary, department of internal medicine, gastroenterology clinic, hepatobiliary clinic, internal medicine ward, high care unit (HCU) and intensive care unit (ICU) Cipto Mangunkusumo Hospital - Faculty of Medicine Universitas Indonesia from May 20, 2021-November 1, 2021. The proposed number of subjects are 130 patients. Interventions will be given in the form of early clear fluid diet initiation compared to active comparator in the form of late clear fluid diet initiation in eligible liver cirrhosis patients who undergo esophageal variceal ligation (EVL) at Cipto Mangunkusumo Hospital. In early diet group diet, the 100 ml of clear fluid will be initiated at 1 hour after EVL followed by standard protocol (clear fluid, soft porridge, porridge, soft rice, regular rice) explained in the arms and intervention column below. In late diet group, the 100 ml of clear fluid will be initiated at 6 hours after EVL, followed by standard protocol (clear fluid, soft porridge, porridge, soft rice, regular rice) explained in the arms and intervention column below. Other routine and standardised drugs for liver cirrhosis patients will still be given. Statistical analysis will use Chi square test with alternative Fisher test for categorical dependent variables and independent T-test with alternative Mann-Whitney test for two group numerical dependent variables.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Liver Cirrhosis
    Keywords
    Esophageal Varices After Ligation, Initiation of Diet, Liver cirrhosis

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    130 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Early Diet Group
    Arm Type
    Experimental
    Arm Description
    1st diet: 100 ml of clear fluid (1 hour after esophageal variceal ligation) 2nd diet: 100 ml of clear fluid (4 hours after the 1st diet) 3rd diet: soft porridge (the amount will be calculated according to patient's caloric needs) which will be given 4 hours after the 2nd diet 4th diet: soft porridge (the amount will be calculated according to patient's caloric needs) which will be given 6 hours after the 3rd diet 5th diet: porridge (the amount will be calculated according to patient's caloric needs) which will be given 6 hours after the 4th diet 6th diet: porridge (the amount will be calculated according to patient's caloric needs) which will be given 6 hours after the 5th diet 7th diet: soft rice (the amount will be calculated according to patient's caloric needs) which will be given 6 hours after the 6th diet 8th diet: regular rice (the amount will be calculated according to patient's caloric needs) which will be given 6 hours after the 7th diet
    Arm Title
    Late Diet Group
    Arm Type
    Active Comparator
    Arm Description
    1st diet : 100 ml of clear fluid (6 hours after esophageal variceal ligation) After the 1st diet (Day 1): 6x100 ml of clear fluid for 24 hours Day 2: soft porridge (the amount will be calculated according to patient's caloric needs) for 24 hours Day 3: porridge (the amount will be calculated according to patient's caloric needs) for 24 hours Day 4: soft rice (the amount will be calculated according to patient's caloric needs) for 24 hours Day 5: regular rice (the amount will be calculated according to patient's caloric needs) for 24 hours and beyond
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Early Diet Group
    Intervention Description
    Initiation of clear fluid diet 1 hour after esophageal variceal ligation
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Late Diet Group
    Intervention Description
    Initiation of clear fluid diet 6 hours after esophageal variceal ligation
    Primary Outcome Measure Information:
    Title
    Early rebleeding event after esophageal variceal ligation
    Description
    Early rebleeding event is hematemesis, melena and/or hematochezia that occurs within 5 days (120 hours) after esophageal variceal ligation
    Time Frame
    This outcome (early rebleeding) will be assessed within 5 days after esophageal variceal ligation
    Secondary Outcome Measure Information:
    Title
    Late rebleeding event after esophageal variceal ligation
    Description
    Late rebleeding event is hematemesis, melena and/or hematochezia that occurs between over than 5 days until 28 days after esophageal variceal ligation
    Time Frame
    This outcome (late rebleeding) will be assessed between over than 5 days until 28 days after esophageal variceal ligation
    Other Pre-specified Outcome Measures:
    Title
    Patient's convenience level regarding initiation of diet after esophageal variceal ligation
    Description
    Patient's convenience is subjectively measured using Visual Analogue Scale (VAS) 0-10 cm with 0 is very unconvenient and 10 is very convenient
    Time Frame
    Patient's convenience will be measured 30 minutes after the patient finished the 1st clear fluid diet

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Liver cirrhosis patients who underwent esophageal variceal ligation Exclusion Criteria: Hemodynamic instability (shock) Possible perforation of the esophagus Esophageal diverticula Esophageal strictures
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rabbinu R Pribadi, MD
    Phone
    +6285885382231
    Email
    rabbinurangga@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Megawati Ananda H Putri, MD
    Phone
    +6281294052702
    Email
    megawatianandadr@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rabbinu R Pribadi, MD
    Organizational Affiliation
    Dr Cipto Mangunkusumo General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    https://scholar.ui.ac.id/en/publications/the-causes-of-upper-gastrointestinal-bleeding-in-the-national-ref
    Description
    Syam AF, Abdullah M, Simadibrata M, Djojoningrat D, Rani A, Manan C. The Causes of Upper Gastrointestinal Bleedingin the National Referral Hospital:Evaluation on Upper Gastrointestinal TractEndoscopic Result in Five Years Period. Indones j gastroenterol.
    URL
    http://www.ncbi.nlm.nih.gov/books/NBK448078/
    Description
    Meseeha M, Attia M. Esophageal Varices. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 [cited 2020 Jul 8].
    URL
    http://inaactamedica.org/book/book_3.pdf
    Description
    Makmun D, Simadibrata M, Fauzi A. Buku Ajar Endoskopi Saluran Cerna. Jakarta: Interna Publishing; 2017.
    URL
    http://pubmed.ncbi.nlm.nih.gov/26341455/
    Description
    Lo G-H, Lin C-W, Hsu Y-C. A controlled trial of early versus delayed feeding following ligation in the control of acute esophageal variceal bleeding. J Chin Med Assoc JCMA. 2015 Nov;78(11):642-7.
    URL
    http://pubmed.ncbi.nlm.nih.gov/31038792/
    Description
    Sidhu SS, Goyal O, Singh S, Kishore H, Chhina RS, Sidhu SS. Early feeding after esophageal variceal band ligation in cirrhotics is safe: Randomized controlled trial. Dig Endosc. 2019 Nov;31(6):646-52.
    URL
    http://pubmed.ncbi.nlm.nih.gov/31700916/
    Description
    Solanki S, Haq K, Chakinala RC,et al. Inpatient burden of esophageal varices in the United States: analysis of trends in demographics, cost of care, and outcomes. Ann Transl Med. 2019 Sep 1;7(18):480.
    URL
    http://pubmed.ncbi.nlm.nih.gov/27324725/
    Description
    Abby Philips C, Sahney A. Oesophageal and gastric varices: historical aspects, classification and grading: everything in one place. Gastroenterol Rep. 2016 Aug;4(3):186-95
    URL
    http://ejim.springeropen.com/track/pdf/10.4103/ejim.ejim_22_18.pdf
    Description
    . Goda T, Mokhtar A, Anwar R, Hakim H, Eleraki A. Effect of early versus delayed feeding following emergency endoscopic therapy for acute esophageal variceal bleeding on short-term outcomes. Egypt J Intern Med. 2018;30(3):110.
    URL
    http://pubmed.ncbi.nlm.nih.gov/17057145/
    Description
    Hafeez M. Sucralfate and Lidocain: Antacid 50:50 solution in Post Esophageal Variceal Band Ligation Pain. Pak J Med Sci. 2016 Jul 1;32(4).
    URL
    http://pubmed.ncbi.nlm.nih.gov/28217433/
    Description
    Klimek L, Bergmann K-C, Biedermann T, Bousquet J, Hellings P, Jung K, et al. Visual analogue scales (VAS): Measuring instruments for the documentation of symptoms and therapy monitoring in cases of allergic rhinitis in everyday health care.
    URL
    http://pubmed.ncbi.nlm.nih.gov/29083349/
    Description
    Leigheb M, Sabbatini M, Baldrighi M, et al. Prospective analysis of pain and pain management in an emergency department.

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