Clinical trial NCT04890210: Initiation of Diet in Esophageal Varices After Ligation (IDEAL) Study
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
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cirrhosis
Keywords: Esophageal Varices After Ligation
Initiation of Diet
Liver cirrhosis
Lead sponsor: Dr Cipto Mangunkusumo General Hospital
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

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

Primary outcomes:
measure: Early rebleeding event after esophageal variceal ligation
timeFrame: This outcome (early rebleeding) will be assessed within 5 days after esophageal variceal ligation
Secondary outcomes:
measure: Late rebleeding event after esophageal variceal ligation
timeFrame: This outcome (late rebleeding) will be assessed between over than 5 days until 28 days after esophageal variceal ligation
Other outcomes:
measure: Patient's convenience level regarding initiation of diet after esophageal variceal ligation
timeFrame: Patient's convenience will be measured 30 minutes after the patient finished the 1st clear fluid diet
Locations:
Study officials:
affiliation: Dr Cipto Mangunkusumo General Hospital
name: Rabbinu R Pribadi, MD
role: PRINCIPAL_INVESTIGATOR
References: