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

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

1. 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.

2. 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).

3. 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Dietary supplement: Early Diet Group; Dietary supplement: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rabbinu R Pribadi, MD; Phone Number: +6285885382231; Email: rabbinurangga@gmail.com
• Study Contact Backup: Name: Megawati Ananda H Putri, MD; Phone Number: +6281294052702; Email: megawatianandadr@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Liver cirrhosis patients who underwent esophageal variceal ligation

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Diet Group; 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	Dietary supplement: Early Diet Group; Initiation of clear fluid diet 1 hour after esophageal variceal ligation
Active Comparator: Late Diet Group; 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	Dietary supplement: Late Diet Group; Initiation of clear fluid diet 6 hours after esophageal variceal ligation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	This outcome (early rebleeding) will be assessed within 5 days after esophageal variceal ligation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	This outcome (late rebleeding) will be assessed between over than 5 days until 28 days after esophageal variceal ligation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's convenience level regarding initiation of diet after esophageal variceal ligation	Patient's convenience is subjectively measured using Visual Analogue Scale (VAS) 0-10 cm with 0 is very unconvenient and 10 is very convenient	Patient's convenience will be measured 30 minutes after the patient finished the 1st clear fluid diet

Collaborators and Investigators

• Sponsor: Dr Cipto Mangunkusumo General Hospital
• Investigators: Principal Investigator: Rabbinu R Pribadi, MD, Dr Cipto Mangunkusumo General Hospital

Publications and helpful links

Helpful Links

• 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.
• Meseeha M, Attia M. Esophageal Varices. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 [cited 2020 Jul 8].
• Makmun D, Simadibrata M, Fauzi A. Buku Ajar Endoskopi Saluran Cerna. Jakarta: Interna Publishing; 2017.
• 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.
• 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.
• 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.
• 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
• . 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.
• 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).
• 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.
• Leigheb M, Sabbatini M, Baldrighi M, et al. Prospective analysis of pain and pain management in an emergency department.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 20, 2021
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: May 14, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): May 18, 2021
• Last Update Submitted That Met QC Criteria: May 14, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Liver cirrhosis; Esophageal Varices After Ligation; Initiation of Diet
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: DCiptoMGH Indonesia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No