Acute Gastroesophageal Variceal BleedingEVLFNCT03306095
Comparison of Early Vs Delayed Feeding on Rebleeding Following Endoscopic Ligation for Acute Esophageal Variceal Bleeding
An observational study of Acute Gastroesophageal Variceal Bleeding, run by Dayanand Medical College and Hospital at 1 site in India.
Trial summary
Following endoscopic therapy of variceal bleeding, the issue of when to refeed these patients has rarely been investigated. This may imply that feeding is generally regarded as a negligible factor in the management of bleeding varices. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Gastroesophageal Variceal Bleeding
- What is being tested?
- Early refeeding group and Delayed refeeding group
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- 2 May 2017to 16 Jul 2018
- How long will I take part?
- 2 Days
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Based on earlier study done by Gin-Ho Lo et al where the prevalence of UGI bleed in early refeeding group was 33 % and late refeeding group was 10 % a sample size required to detect any significant difference was found to be 88. Adding to which 10 % of attrition a total sample size of 100 was taken.
Who may be able to join
- Presence of Portal Hypertension with or without cirrhosis.
- 18 and 80 years of age.
- Prophylactic EVL
- EVL was performed as maintenance treatment for Past history of bleeding varices
- Emergency endoscopic EVL for acutely bleeding varices.
Who cannot join
- Septicemia
- Patients with advanced hepatocellular carcinoma (HCC)
- Failure to control variceal bleeding by emergency endoscopic therapy.
- Uncooperative patient
- Patient with endotracheal intubation.
- Ever received EIS or EVL within 1 month prior to index bleeding.
- Child Pugh's scores >13.
- Presence of Overt hepatic encephalopathy
Trial locations and contacts
1 site in 1 country.
About this study
Following endoscopic therapy of variceal bleeding, the issue of when to refeed these patients has rarely been investigated. This may imply that feeding is generally regarded as a negligible factor in the management of bleeding varices. On the other hand, it is usually believed that systematic fasting is required in case of patients with upper gastrointestinal bleeding.
Some researchers in their studies demonstrated that immediate refeeding has similar outcomes to delayed refeeding among patients with low risk of nonvariceal bleeding. The situation of variceal bleeding is quite different from that of peptic ulcer bleeding as demonstrated by studies of other researchers who made a review on feeding of patients with upper gastrointestinal bleeding, and recommended that feeding should be delayed for at least 48 hours after endoscopic therapy because early refeeding may cause a shift in blood flow to the splanchnic circulation, which in turn could lead to an increase in pressure and an increased risk of rebleeding from the varices.
The other important reason of delay in feeding may be ascribed to the fear of occurrence of early rebleeding induced by refeeding. In addition, repeated endoscopic examination and therapy may be required in patients with very early rebleeding. The decision to delay feeding is usually based on clinicians 'experience or experts' opinion rather than evidence based. That is why we planned this study.
Read the detailed description
There has not been much studies conducted to address this issue however most of the recommendations are made in view of preventing any complications following procedures. Stiegmann and Goff 4 were the first to employ EVL to treat esophageal varices. They did not mention any specific restriction of feeding on patients receiving band ligation however they did mentioned that following the band ligation of varices, the ligated varices and tissues may evoke transient dysphagia to solid food.5 A study conducted by Gin Ho Lo et al 6 demonstrated that early feeding with a liquid diet in conscious patients after successful endoscopic therapy of varices can shorten the hospital stay. The two groups which were created in this study were the early-feeding group and the delayed-feeding group. Patients in the early-feeding group were asked to fast for only 4 hours following endoscopic treatment. Subsequently, a liquid diet (fruit juice, soybean juice, milk, rice in liquid form) was instituted for 3 days. Additionally, <500 cc intravenous fluid with proper electrolyte supplement per day was administered. Thereafter, a soft diet was provided for 3 days, after which a regular diet was resumed since the seventh day after endoscopic treatment. Patients in the delayed-feeding group were asked to absolutely fast for 48 hours after endoscopic treatment, and 1500 cc/day intravenous fluids (normal saline or glucose water) with proper electrolytes were administered for 2 days. After 2 days of fasting, a liquid diet was given for 1 day, and subsequently, a soft diet was given for 3 days, and then a regular diet was instituted on the seventh day after endoscopic treatment. If rebleeding occurred within 7 days of endoscopic therapy, patients in both groups were again asked to fast for 48 hours, and then put on a liquid diet for 1 day followed by a soft diet for 4 days.
Treatment failure was defined as failure to control acute bleeding episodes or very early rebleeding or death within 5 days. Failure to control acute variceal bleeding was defined as the occurrence of any of the following events within 48 hours of enrollment, based on the modified criteria of the Baveno III consensus:7 (1) fresh hematemesis after enrollment; (2) sudden onset of reduction in blood pressure of _20 mmHg and/or an increase in pulse rate of 20 beats/minute with 2 g drop in hemoglobin; (3) transfusion of four units of blood required to increase the hematocrit to above 27% or hemoglobin to above 9 g/dL; and (4) death. Very early rebleeding was defined as when the criteria for failure to control acute variceal bleeding occurred between 48 hours and 120 hours after enrollment in patients achieving control of acute bleeding. Control of acute bleeding (initial hemostasis) was defined as when the criteria for failure did not occur within 48 hours of enrollment. A 5-day hemostasis was defined as when the criteria for failure to control acute variceal bleeding and very early rebleeding did not occur within 5 days of enrollment. A nasogastric tube was not routinely inserted after initial endoscopy.
The rebleeding rates associated with EVL varied greatly between studies, and rates ranging from 2% to 54% have been recorded.8,9 Aside from other reasons, this discrepancy is very likely to be related to the variation in timing of refeeding after EVL. However, this factor was rarely mentioned in the methodology of these studies A review article by Xavier He´buterne 10 concluded that In patients hospitalized for acute upper gastrointestinal bleeding due to an ulcer with high risk of rebleeding (Forrest I-IIb) or with variceal bleeding it is recommended to wait at least 48 h after endoscopic therapy before initiating oral or enteral feeding. In case of ulcer with low risk of rebleeding (Forrest IIc and III) or in patients with gastritis, Mallory-Weiss, oesophagitis, or angiodysplasia, there is no need to delay refeeding, and they can be fed as soon as tolerated. Understanding the cause of the diagnosis is always necessary to adapt nutrition in patients with upper gastrointestinal bleeding.
- Conditions
- Acute Gastroesophageal Variceal Bleeding
- Being tested
- Early refeeding group, Delayed refeeding group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early refeeding groupOther
Food Intake by patient with in 4 hours i.e <4 hours after the EVL procedure
Delayed refeeding groupOther
Food Intake by patient after 4 hours i.e > 4 hours after the EVL procedure
| Study group | Role | What they receive |
|---|---|---|
| Early refeeding group | Food Intake by patient with in 4 hours i.e <4 hours after the EVL procedure Receives: Other: Early refeeding group; Other: Delayed refeeding group | |
| Delayed refeeding group | Food Intake by patient with in 4 hours i.e > 4 hours after the EVL procedure Receives: Other: Early refeeding group; Other: Delayed refeeding group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding
Early Re bleed Rate versus delayed variceal re bleed rate
Measured: 48 hour
Secondary outcomes (2)
Mortality
Mortality rate following early and late feeding
Measured: 48 hour
Hemostasis
Hemostasis
Measured: 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start2 May 2017
- Primary completion1 May 2018
- Study completion16 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Gastroesophageal Variceal BleedingStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Dayanand Medical College and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Sandeep S Sidhu, Dayanand Medical College and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306095
- Sponsor's protocol ID
- EVLF2017
- Acronym
- EVLF
- Status last verified
- Jul 2018
- First submitted
- 29 Sep 2017
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hebuterne X, Vanbiervliet G. Feeding the patients with upper gastrointestinal bleeding. Curr Opin Clin Nutr Metab Care. 2011 Mar;14(2):197-201. doi: 10.1097/MCO.0b013e3283436dc5.
PubMed 21252654Laine L, Cohen H, Brodhead J, Cantor D, Garcia F, Mosquera M. Prospective evaluation of immediate versus delayed refeeding and prognostic value of endoscopy in patients with upper gastrointestinal hemorrhage. Gastroenterology. 1992 Jan;102(1):314-6. doi: 10.1016/0016-5085(92)91816-m.
PubMed 1727765Laine L, Jensen DM. Management of patients with ulcer bleeding. Am J Gastroenterol. 2012 Mar;107(3):345-60; quiz 361. doi: 10.1038/ajg.2011.480. Epub 2012 Feb 7.
PubMed 22310222Lo GH, Lin CW, Hsu YC. A controlled trial of early versus delayed feeding following ligation in the control of acute esophageal variceal bleeding. J Chin Med Assoc. 2015 Nov;78(11):642-7. doi: 10.1016/j.jcma.2015.07.004. Epub 2015 Sep 2.
PubMed 26341455Garcia-Tsao G, Bosch J. Management of varices and variceal hemorrhage in cirrhosis. N Engl J Med. 2010 Mar 4;362(9):823-32. doi: 10.1056/NEJMra0901512. No abstract available.
PubMed 20200386Lo GH. Management of acute esophageal variceal hemorrhage. Kaohsiung J Med Sci. 2010 Feb;26(2):55-67. doi: 10.1016/s1607-551x(10)70009-7.
PubMed 20123593
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Early Vs Delayed Feeding on Rebleeding Following Endoscopic Ligation for Acute Esophageal Variceal Bleeding
- ClinicalTrials.gov ID
- NCT03306095
- Acronym / sponsor ID
- EVLF / EVLF2017
- Conditions
- Acute Gastroesophageal Variceal Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Dayanand Medical College and HospitalUniversity, hospital or other
- Study start
- 2 May 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 16 Jul 2018 (actual)
- First posted
- 10 Oct 2017 (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.
Following endoscopic therapy of variceal bleeding, the issue of when to refeed these patients has rarely been investigated. This may imply that feeding is generally regarded as a negligible factor in the management of bleeding varices. On the other hand, it is usually believed that systematic fasting is required in case of patients with upper gastrointestinal bleeding.
Some researchers in their studies demonstrated that immediate refeeding has similar outcomes to delayed refeeding among patients with low risk of nonvariceal bleeding. The situation of variceal bleeding is quite different from that of peptic ulcer bleeding as demonstrated by studies of other researchers who made a review on feeding of patients with upper gastrointestinal bleeding, and recommended that feeding should be delayed for at least 48 hours after endoscopic therapy because early refeeding may cause a shift in blood flow to the splanchnic circulation, which in turn could lead to an increase in pressure and an increased risk of rebleeding from the varices.
The other important reason of delay in feeding may be ascribed to the fear of occurrence of early rebleeding induced by refeeding. In addition, repeated endoscopic examination and therapy may be required in patients with very early rebleeding. The decision to delay feeding is usually based on clinicians 'experience or experts' opinion rather than evidence based. That is why we planned this study.
Detailed description
There has not been much studies conducted to address this issue however most of the recommendations are made in view of preventing any complications following procedures. Stiegmann and Goff 4 were the first to employ EVL to treat esophageal varices. They did not mention any specific restriction of feeding on patients receiving band ligation however they did mentioned that following the band ligation of varices, the ligated varices and tissues may evoke transient dysphagia to solid food.5 A study conducted by Gin Ho Lo et al 6 demonstrated that early feeding with a liquid diet in conscious patients after successful endoscopic therapy of varices can shorten the hospital stay. The two groups which were created in this study were the early-feeding group and the delayed-feeding group. Patients in the early-feeding group were asked to fast for only 4 hours following endoscopic treatment. Subsequently, a liquid diet (fruit juice, soybean juice, milk, rice in liquid form) was instituted for 3 days. Additionally, <500 cc intravenous fluid with proper electrolyte supplement per day was administered. Thereafter, a soft diet was provided for 3 days, after which a regular diet was resumed since the seventh day after endoscopic treatment. Patients in the delayed-feeding group were asked to absolutely fast for 48 hours after endoscopic treatment, and 1500 cc/day intravenous fluids (normal saline or glucose water) with proper electrolytes were administered for 2 days. After 2 days of fasting, a liquid diet was given for 1 day, and subsequently, a soft diet was given for 3 days, and then a regular diet was instituted on the seventh day after endoscopic treatment. If rebleeding occurred within 7 days of endoscopic therapy, patients in both groups were again asked to fast for 48 hours, and then put on a liquid diet for 1 day followed by a soft diet for 4 days.
Treatment failure was defined as failure to control acute bleeding episodes or very early rebleeding or death within 5 days. Failure to control acute variceal bleeding was defined as the occurrence of any of the following events within 48 hours of enrollment, based on the modified criteria of the Baveno III consensus:7 (1) fresh hematemesis after enrollment; (2) sudden onset of reduction in blood pressure of _20 mmHg and/or an increase in pulse rate of 20 beats/minute with 2 g drop in hemoglobin; (3) transfusion of four units of blood required to increase the hematocrit to above 27% or hemoglobin to above 9 g/dL; and (4) death. Very early rebleeding was defined as when the criteria for failure to control acute variceal bleeding occurred between 48 hours and 120 hours after enrollment in patients achieving control of acute bleeding. Control of acute bleeding (initial hemostasis) was defined as when the criteria for failure did not occur within 48 hours of enrollment. A 5-day hemostasis was defined as when the criteria for failure to control acute variceal bleeding and very early rebleeding did not occur within 5 days of enrollment. A nasogastric tube was not routinely inserted after initial endoscopy.
The rebleeding rates associated with EVL varied greatly between studies, and rates ranging from 2% to 54% have been recorded.8,9 Aside from other reasons, this discrepancy is very likely to be related to the variation in timing of refeeding after EVL. However, this factor was rarely mentioned in the methodology of these studies A review article by Xavier He´buterne 10 concluded that In patients hospitalized for acute upper gastrointestinal bleeding due to an ulcer with high risk of rebleeding (Forrest I-IIb) or with variceal bleeding it is recommended to wait at least 48 h after endoscopic therapy before initiating oral or enteral feeding. In case of ulcer with low risk of rebleeding (Forrest IIc and III) or in patients with gastritis, Mallory-Weiss, oesophagitis, or angiodysplasia, there is no need to delay refeeding, and they can be fed as soon as tolerated. Understanding the cause of the diagnosis is always necessary to adapt nutrition in patients with upper gastrointestinal bleeding.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early refeeding group | – | Other: Early refeeding group, Other: Delayed refeeding groupFood Intake by patient with in 4 hours i.e <4 hours after the EVL procedure |
| Delayed refeeding group | – | Other: Early refeeding group, Other: Delayed refeeding groupFood Intake by patient with in 4 hours i.e > 4 hours after the EVL procedure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Based on earlier study done by Gin-Ho Lo et al where the prevalence of UGI bleed in early refeeding group was 33 % and late refeeding group was 10 % a sample size required to detect any significant difference was found to be 88. Adding to which 10 % of attrition a total sample size of 100 was taken.
Key inclusion criteria (5 listed)
- Presence of Portal Hypertension with or without cirrhosis.
- 18 and 80 years of age.
- Prophylactic EVL
- EVL was performed as maintenance treatment for Past history of bleeding varices
- Emergency endoscopic EVL for acutely bleeding varices.
Key exclusion criteria (8 listed)
- Septicemia
- Patients with advanced hepatocellular carcinoma (HCC)
- Failure to control variceal bleeding by emergency endoscopic therapy.
- Uncooperative patient
- Patient with endotracheal intubation.
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 refeeding groupFood Intake by patient with in 4 hours i.e <4 hours after the EVL procedure | Other | Delayed refeeding group, Early refeeding group |
| Delayed refeeding groupFood Intake by patient after 4 hours i.e > 4 hours after the EVL procedure | Other | Delayed refeeding group, Early refeeding group |
Primary outcome
Bleeding
Time frame: 48 hour
Early Re bleed Rate versus delayed variceal re bleed rate
2 secondary outcomes
Mortality
Time frame: 48 hour
Hemostasis
Time frame: 48 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Results publication: PubMed 21252654Hebuterne X, Vanbiervliet G. Feeding the patients with upper gastrointestinal bleeding. Curr Opin Clin Nutr Metab Care. 2011 Mar;14(2):197-201. doi: 10.1097/MCO.0b013e3283436dc5.
- Results publication: PubMed 1727765Laine L, Cohen H, Brodhead J, Cantor D, Garcia F, Mosquera M. Prospective evaluation of immediate versus delayed refeeding and prognostic value of endoscopy in patients with upper gastrointestinal hemorrhage. Gastroenterology. 1992 Jan;102(1):314-6. doi: 10.1016/0016-5085(92)91816-m.
- Results publication: PubMed 22310222Laine L, Jensen DM. Management of patients with ulcer bleeding. Am J Gastroenterol. 2012 Mar;107(3):345-60; quiz 361. doi: 10.1038/ajg.2011.480. Epub 2012 Feb 7.
- Results publication: PubMed 26341455Lo GH, Lin CW, Hsu YC. A controlled trial of early versus delayed feeding following ligation in the control of acute esophageal variceal bleeding. J Chin Med Assoc. 2015 Nov;78(11):642-7. doi: 10.1016/j.jcma.2015.07.004. Epub 2015 Sep 2.
- Results publication: PubMed 20200386Garcia-Tsao G, Bosch J. Management of varices and variceal hemorrhage in cirrhosis. N Engl J Med. 2010 Mar 4;362(9):823-32. doi: 10.1056/NEJMra0901512. No abstract available.
- Results publication: PubMed 20123593Lo GH. Management of acute esophageal variceal hemorrhage. Kaohsiung J Med Sci. 2010 Feb;26(2):55-67. doi: 10.1016/s1607-551x(10)70009-7.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Gastroesophageal Variceal Bleeding, run by Dayanand Medical College and Hospital at 1 site in India.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding (time frame: 48 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03306095, which also lists 6 linked publications.
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 31 Jul 2018.