Back to resultsTiming of Endoscopy in Cirrhotic Patients With Acute Variceal Bleeding
Primary Purpose
Acute Upper Gastrointestinal Bleeding, Acute Variceal Bleeding
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endoscopy
Sponsored by
About this trial
This is an interventional treatment trial for Acute Upper Gastrointestinal Bleeding focused on measuring liver cirrhosis, variceal bleeding, gastrointestinal bleeding, endoscopy, survival, randomized controlled trial
Eligibility Criteria
Inclusion Criteria: patients with AUGIB which is highly suspected to be caused by gastroesophageal variceal rupture; patients with a diagnosis of liver cirrhosis based on imaging and pathology; patients and/or their relatives who sign informed consents; patients' age ≥18 years. Exclusion Criteria: patients who have undergone endoscopy at other hospitals before admissions; patients' hemodynamics are unstable after resuscitation; patients with severe cardiovascular or cerebrovascular diseases or renal injury; patients who have taken anticoagulants or antiplatelet drugs within 2 weeks before admissions, or are diagnosed with severe hematological diseases; patients with human immunodeficiency virus or other acquired or congenital immune deficiency diseases; patients with mental illness; pregnancy.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Early endoscopy group
Delayed endoscopy group
Arm Description
Intervention of endoscopy is within 12 hours after admission
Intervention of endoscopy is within 12-24 hours after admission
Outcomes
Primary Outcome Measures
The failure to control bleeding after admissions
Failure to control bleeding is defined as any one of the three following conditions within 5 days admission: 1) vomiting of fresh blood; 2) suction of more than 100ml of fresh blood from the nasogastric tube; 3) a decrease in hemoglobin concentration of 30g/L in the absence of blood transfusion; or 4) death.
6-week rebleeding
Rebleeding is defined as new onset of hematemesis or melena after successful treatment.
Secondary Outcome Measures
6-week all-cause mortality
Death
Adverse events
Adverse events include fever, chest pain, dysphagia, and perforation or pneumonia caused by endoscopy or anesthesia during this trial.
Full Information
NCT ID
NCT06031402
First Posted
August 30, 2023
Last Updated
September 8, 2023
Sponsor
General Hospital of Shenyang Military Region
1. Study Identification
Unique Protocol Identification Number
NCT06031402
Brief Title
Timing of Endoscopy in Cirrhotic Patients With Acute Variceal Bleeding
Official Title
Timing of Endoscopy in Cirrhotic Patients With Acute Variceal Bleeding
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General Hospital of Shenyang Military Region
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Endoscopy is important for the diagnosis and treatment of acute upper gastrointestinal bleeding (AUGIB), especially acute variceal bleeding (AVB), in patients with liver cirrhosis. However, the optimal timing of endoscopy remains controversial, primarily because the currently available evidence is of poor quality, and the definition of early endoscopy is also very heterogeneous among studies. Herein, a multicenter randomized controlled trial (RCT) is performed to explore the impact of timing of endoscopy on the outcomes of cirrhotic patients with AVB.
Detailed Description
A total of 368 cirrhotic patients presenting with AUGIB that is highly suspected to be from AVB will be enrolled. They will be stratified according to the severity of liver function and hemodynamic status at admission, and randomly assigned at a 1:1 ratio into early (within 12 hours after admission) and delayed (within 12-24 hours after admission) endoscopy groups within each stratum. The primary outcomes include the rates of 5-day failure to control bleeding after admission and 6-week rebleeding. The secondary outcomes include 6-week mortality and incidence of adverse events.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Upper Gastrointestinal Bleeding, Acute Variceal Bleeding
Keywords
liver cirrhosis, variceal bleeding, gastrointestinal bleeding, endoscopy, survival, randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Before enrollment, all patients and/or their relatives will be informed about the study protocol, and sign the written informed consent forms. Eligible patients are randomly assigned at a ratio of 1:1 to early endoscopy group (within 12 hours after admission) and delayed endoscopy group (within 12-24 hours after admission)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
368 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early endoscopy group
Arm Type
Experimental
Arm Description
Intervention of endoscopy is within 12 hours after admission
Arm Title
Delayed endoscopy group
Arm Type
Active Comparator
Arm Description
Intervention of endoscopy is within 12-24 hours after admission
Intervention Type
Procedure
Intervention Name(s)
Endoscopy
Intervention Description
Endoscopy
Primary Outcome Measure Information:
Title
The failure to control bleeding after admissions
Description
Failure to control bleeding is defined as any one of the three following conditions within 5 days admission: 1) vomiting of fresh blood; 2) suction of more than 100ml of fresh blood from the nasogastric tube; 3) a decrease in hemoglobin concentration of 30g/L in the absence of blood transfusion; or 4) death.
Time Frame
within 5 days admission
Title
6-week rebleeding
Description
Rebleeding is defined as new onset of hematemesis or melena after successful treatment.
Time Frame
6-week
Secondary Outcome Measure Information:
Title
6-week all-cause mortality
Description
Death
Time Frame
6-week
Title
Adverse events
Description
Adverse events include fever, chest pain, dysphagia, and perforation or pneumonia caused by endoscopy or anesthesia during this trial.
Time Frame
up to 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with AUGIB which is highly suspected to be caused by gastroesophageal variceal rupture;
patients with a diagnosis of liver cirrhosis based on imaging and pathology;
patients and/or their relatives who sign informed consents;
patients' age ≥18 years.
Exclusion Criteria:
patients who have undergone endoscopy at other hospitals before admissions;
patients' hemodynamics are unstable after resuscitation;
patients with severe cardiovascular or cerebrovascular diseases or renal injury;
patients who have taken anticoagulants or antiplatelet drugs within 2 weeks before admissions, or are diagnosed with severe hematological diseases;
patients with human immunodeficiency virus or other acquired or congenital immune deficiency diseases;
patients with mental illness;
pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xingshun Qi, MD
Phone
86-18909881019
Email
xingshunqi@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xingshun Qi, MD
Organizational Affiliation
General Hospital of Shenyang Military Area
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mostafa Ibrahim, MD
Organizational Affiliation
Theodor Bilharz Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yiling Li, MD
Organizational Affiliation
First Hospital of China Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bimin Li, MD
Organizational Affiliation
The First Affiliated Hospital of Nanchang University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xuefeng Luo, MD
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaofeng Liu, MD
Organizational Affiliation
The 960th Hospital of the Chinese People's Liberation Army
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chunqing Zhang, MD
Organizational Affiliation
Affiliated Provincial Hospital of Shandong First Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mingkai Chen, MD
Organizational Affiliation
People's Hospital of Wuhan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Derun Kong, MD
Organizational Affiliation
The First Affiliated Hospital of Anhui Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fernando G Romeiro, MD
Organizational Affiliation
Botucatu Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrea Mancuso, MD
Organizational Affiliation
Azienda di Rilievo Nazionale ad Alta Specializzazione Civico-Di Cristina-Benfratelli
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nahum Méndez-Sánchez, MD
Organizational Affiliation
Medica Sur Clinic and Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Enqiang Linghu, MD
Organizational Affiliation
The First Medical Center of Chinese PLA General Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35048654
Citation
Bai Z, Wang R, Cheng G, Ma D, Ibrahim M, Chawla S, Qi X. Outcomes of early versus delayed endoscopy in cirrhotic patients with acute variceal bleeding: a systematic review with meta-analysis. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e868-e876. doi: 10.1097/MEG.0000000000002282.
Results Reference
background
PubMed Identifier
25785053
Citation
Peng Y, Qi X, Dai J, Li H, Guo X. Child-Pugh versus MELD score for predicting the in-hospital mortality of acute upper gastrointestinal bleeding in liver cirrhosis. Int J Clin Exp Med. 2015 Jan 15;8(1):751-7. eCollection 2015.
Results Reference
background
PubMed Identifier
26937922
Citation
Peng Y, Qi X, Guo X. Child-Pugh Versus MELD Score for the Assessment of Prognosis in Liver Cirrhosis: A Systematic Review and Meta-Analysis of Observational Studies. Medicine (Baltimore). 2016 Feb;95(8):e2877. doi: 10.1097/MD.0000000000002877.
Results Reference
background
PubMed Identifier
31524777
Citation
Li Y, Li H, Zhu Q, Tsochatzis E, Wang R, Guo X, Qi X. Effect of acute upper gastrointestinal bleeding manifestations at admission on the in-hospital outcomes of liver cirrhosis: hematemesis versus melena without hematemesis. Eur J Gastroenterol Hepatol. 2019 Nov;31(11):1334-1341. doi: 10.1097/MEG.0000000000001524.
Results Reference
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Timing of Endoscopy in Cirrhotic Patients With Acute Variceal Bleeding
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