Liver CirrhosisIDEALNCT04890210
Initiation of Diet in Esophageal Varices After Ligation (IDEAL) Study
A study testing Early Diet Group and Late Diet Group in people with Liver Cirrhosis, run by Dr Cipto Mangunkusumo General Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Early Diet Group and Late Diet Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2021to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Liver cirrhosis patients who underwent esophageal variceal ligation
Who cannot join
- Hemodynamic instability (shock)
- Possible perforation of the esophagus
- Esophageal diverticula
- Esophageal strictures
Trial locations and contacts
No sites are listed yet.
About this 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
- 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.
Read the 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.
- Conditions
- Liver Cirrhosis
- Being tested
- Early Diet Group, Late Diet Group
- Keywords
- Esophageal Varices After Ligation, Initiation of Diet, Liver cirrhosis
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Diet GroupDietary supplement
Initiation of clear fluid diet 1 hour after esophageal variceal ligation
Late Diet GroupDietary supplement
Initiation of clear fluid diet 6 hours after esophageal variceal ligation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Late Diet Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: This outcome (early rebleeding) will be assessed within 5 days after esophageal variceal ligation
Secondary outcomes (1)
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
Measured: This outcome (late rebleeding) will be assessed between over than 5 days until 28 days after esophageal variceal ligation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start20 May 2021 (estimated)
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Cipto Mangunkusumo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabbinu Rangga Pribadi, MD, Dr Cipto Mangunkusumo General Hospital
- Investigators
- Rabbinu R Pribadi, MD, Principal investigator, Dr Cipto Mangunkusumo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890210
- Sponsor's protocol ID
- DCiptoMGH Indonesia
- Acronym
- IDEAL
- Status last verified
- May 2021
- First submitted
- 6 May 2021
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04890210
- Acronym / sponsor ID
- IDEAL / DCiptoMGH Indonesia
- Conditions
- Liver Cirrhosis
- Keywords
- Esophageal Varices After Ligation, Initiation of Diet, Liver cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Dr Cipto Mangunkusumo General HospitalUniversity, hospital or other
- Study start
- 20 May 2021 (estimated)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Diet Group | Experimental | Dietary Supplement: 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 |
| Late Diet Group | Active comparator | Dietary Supplement: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Liver cirrhosis patients who underwent esophageal variceal ligation
Key exclusion criteria (4 listed)
- Hemodynamic instability (shock)
- Possible perforation of the esophagus
- Esophageal diverticula
- Esophageal strictures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Diet GroupInitiation of clear fluid diet 1 hour after esophageal variceal ligation | Dietary supplement | Early Diet Group |
| Late Diet GroupInitiation of clear fluid diet 6 hours after esophageal variceal ligation | Dietary supplement | Late Diet Group |
Primary outcome
Early rebleeding event after esophageal variceal ligation
Time frame: This outcome (early rebleeding) will be assessed within 5 days after esophageal variceal ligation
Early rebleeding event is hematemesis, melena and/or hematochezia that occurs within 5 days (120 hours) after esophageal variceal ligation
1 secondary outcome
Late rebleeding event 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- 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.Link provided by the sponsor.
- Meseeha M, Attia M. Esophageal Varices. In: StatPearls \[Internet\]. Treasure Island (FL): StatPearls Publishing; 2020 \[cited 2020 Jul 8\].Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rabbinu R Pribadi, MD principal investigator
Dr Cipto Mangunkusumo General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Early Diet Group and Late Diet Group in people with Liver Cirrhosis, run by Dr Cipto Mangunkusumo General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rabbinu R Pribadi, MD (+6285885382231, rabbinurangga@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early rebleeding event after esophageal variceal ligation (time frame: This outcome (early rebleeding) will be assessed within 5 days after esophageal variceal ligation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.