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

NCT04890210 | Unknown

• 1 other identifier: DCiptoMGH Indonesia
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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. 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).
3. 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.

Conditions

Liver Cirrhosis

Keywords

Esophageal Varices After Ligation; Initiation of Diet; Liver cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Late rebleeding event after esophageal variceal ligation

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

Other Outcomes (1)

• Patient's convenience level regarding initiation of diet after esophageal variceal ligation

  Patient's convenience will be measured 30 minutes after the patient finished the 1st clear fluid diet

Study Arms (2)

Early Diet Group

EXPERIMENTAL

* 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

Late Diet Group

ACTIVE COMPARATOR

* 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

Interventions

Early Diet Group DIETARY_SUPPLEMENT

Initiation of clear fluid diet 1 hour after esophageal variceal ligation

Early Diet Group

Late Diet Group DIETARY_SUPPLEMENT

Initiation of clear fluid diet 6 hours after esophageal variceal ligation

Late Diet Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Liver cirrhosis patients who underwent esophageal variceal ligation

You may not qualify if:

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

Sponsors & Collaborators

• Dr Cipto Mangunkusumo General Hospital: lead

Related 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.
• Kalista KF, Lesmana CRA, Sulaiman AS, Gani RA, Hasan I. Profil Klinis Pasien Sirosis Hati dengan Varises Esofagus yang Menjalani Ligasi Varises Esofagus di Rumah Sakit Dr. Cipto Mangunkusumo. J Penyakit Dalam Indones. 2019 Mar 31;6(1):36.
• 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.

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rabbinu R Pribadi, MD

  Dr Cipto Mangunkusumo General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rabbinu R Pribadi, MD

CONTACT

+6285885382231; rabbinurangga@gmail.com

Megawati Ananda H Putri, MD

CONTACT

+6281294052702; megawatianandadr@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager of Division of Gastroenterology, Department of Internal Medicine

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 18, 2021
• Study Start: May 20, 2021
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 18, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share