NCT01287702

Brief Summary

The impact of feeding after endoscopic treatment of gastroesophageal varices has never been investigated. It is still unknown whether early feeding may increase early rebleeding in patients with acute esophageal variceal bleeding treated with EVL. It is customary for clinicians to institute fasting for 2 or 3 days after emergency EVL. This may be a safe approach to watch against early rebleeding. However, many patients would be fasting for a longer time and nutrition may be impaired, possibly resulting in aggravation of ascites. Thus, the investigators conduct a controlled study to evaluate whether early feeding have a bad impact on patients receiving emergency EVL or histoacryl injection for bleeding gastric varices.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

March 2, 2011

Status Verified

February 1, 2011

Enrollment Period

2.5 years

First QC Date

January 31, 2011

Last Update Submit

February 28, 2011

Conditions

Varices

Keywords

early feedingvarices bleedingto evaluate impact of early feeding on early rebleeding after ligation of varices

Outcome Measures

Primary Outcomes (3)

  • Success rate of initial hemostasis

    hemostasis for 48 hours after ligation

    48 hours

  • very early rebleeding rate

    rebleeding during this period

    48- 120 hours

  • ulcer bleeding rate

    14 days after ligation of varices

    14 days

Secondary Outcomes (1)

  • The amount of blood transfuion and mortality

    14 days

Study Arms (2)

Early feeding

EXPERIMENTAL

patients receiving EVL will receive liquid diet since 4 hours after arresting of variceal bleedingpatients with acute bleeding varices arrested by EVL

Dietary Supplement: Early feeding

Dealyed feeding

ACTIVE COMPARATOR

patients with acute bleeding varices arrested by EVL, will receive feeding 48 hours after EVL.

Dietary Supplement: Delayed feedingDietary Supplement: Dealyed feeding

Interventions

Delayed feedingDIETARY_SUPPLEMENT

patients with acute bleeding varices arrested by EVL, will receive feeding 48 hours after EVL

Dealyed feeding
Dealyed feedingDIETARY_SUPPLEMENT

patients with acute bleeding varices arrested by EVL, will receive feeding 48 hours after EVL

Dealyed feeding
Early feedingDIETARY_SUPPLEMENT

patients receiving EVL will receive liquid diet since 4 hours after arresting of variceal bleedingpatients with acute bleeding varices arrested by EVL

Early feeding

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The etiology of portal hypertension is cirrhosis.
  • Age ranges between 20-80 y/o.
  • Patients presenting with acute gastroesophageal variceal bleeding proven by emergency endoscopy within 12 hours. (Acute esophageal variceal bleeding was defined as: 1) when blood was directly seen by endoscopy to issue from an esophageal varix (active bleeding), or 2) when patients presented with red color signs on their esophageal varices with blood in esophagus or stomach and no other potential site of bleeding identified (inactive bleeding). Gastric variceal bleeding is defined as active spurting from a gastric varix or presence of red spots on a gastric varix.
  • EVL is performed after confirmation of acute esophageal variceal bleeding. Histoacryl injection is performed if acute gastric variceal bleeding is diagnosed. Bleeding is arrested on the spot.

You may not qualify if:

  • association with severe systemic illness, such as sepsis, COPD, uremia, HCC, \> BCLC stage B
  • failure in the control of bleeding by emergency endoscopic treatment.
  • moribund patients, died within 12 hours of enrollment
  • Uncooperative
  • Ever received EIS, EVL within one month prior to index bleeding
  • Child-Pugh's scores \> 13
  • Deep jaundice (serum bilirubin \> 10 mg/dl), presence of encephalopathy \> stage II or massive ascites

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

E-DA hospital

Kaohsiung City, 824, Taiwan

RECRUITING

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 31, 2011

First Posted

February 1, 2011

Study Start

January 1, 2011

Primary Completion

July 1, 2013

Study Completion

October 1, 2013

Last Updated

March 2, 2011

Record last verified: 2011-02

Locations

TW(1)