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Timing of Endoscopic Intervention for Acute Variceal Hemorrhage: an RCT (TEACH)

Primary Purpose

Acute Upper Gastrointestinal Hemorrhage, Cirrhosis, Varice Bleed

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
endoscopic intervention
Sponsored by
Jinling Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Upper Gastrointestinal Hemorrhage focused on measuring Endoscopic intervention; Acute variceal hemorrhage; RCT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

(I) patients who conform to variceal bleeding under endoscopy; (II) patients who have pathological or clinical and imaging evidence according with the diagnosis of cirrhosis; (III) clinical symptoms associated with AVB (hematemesis/melena/hematochezia) before admission or during hospitalization; (IV) hemodynamically stable before or after initial fluid resuscitation.

Exclusion Criteria:

(I) pregnancy; (II) lactation period; (III) less than 18 years.

Sites / Locations

  • Affiliated Jinling Hospital, Medical School of Nanjing UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

non-urgent endoscopy group

urgent endoscopy group

Arm Description

undergo endoscopy between 6 and 24 hours after gastroenterological consultation

undergo endoscopy within 6 hours after gastroenterological consultation

Outcomes

Primary Outcome Measures

Rebleeding
Rebleeding refers to recurrent bleeding after the control of AVH, which is defined as the occurrence of at least one of the following items: (I) hematemesis, melena or hematochezia; (II) decrease in SBP of more than 20 mmHg from the original level or an increase in heart rate of 20 beats/min; and (III) decrease in hemoglobin level of 30 g/L in the absence of a blood transfusion.

Secondary Outcome Measures

Mortality
After undergoing randomization, mortality from any causes within 42 days after randomization will be recorded.
Persistent bleeding
Persistent bleeding refers to bleeding that can not be controlled after initial endoscopic intervention within 24h. Persistent bleeding are defined as follows (at least one item appears): (I) vomiting of fresh blood or suction of more than 100 ml of fresh blood from the nasogastric tube; (II) occurrence of hemorrhagic shock; and (III) decrease in hemoglobin level of 30 g/L in the absence of a blood transfusion.
length of hospitalization
To record how long the patients stay at the hospital.
Transfers to the ICU
To record whether the patients are transferred to ICU.
Secondary endoscopic intervention
To record the secondary endoscopic intervention because of rebleeding or persistent bleeding.
Blood transfusion therapy
To record any blood transfusion therapy.
In-hospital costs
To record all the in-hospital costs.
Adverse events
To record any adverse events that occur during the follow-up.
Transfers to undergo TIPSS
To record patients with persistent bleeding or re-bleeding transferred to undergo TIPSS.
Transfers to undergo surgery
To record patients with persistent bleeding or re-bleeding transferred to undergo surgery.
Concurrent infection
To record infection related to endoscopic intervention.
The patient's position
To record the patient's primary position during endoscopy.
Application of external cannula for endoscopy
The external cannula for endoscopy is used to prevent aspiration according to the patient's condition.
Secondary prophylaxis
To record application of secondary prophylaxis (such as endoscopic intervention, TIPSS and surgery) during the follow-up.

Full Information

First Posted
March 5, 2021
Last Updated
December 9, 2022
Sponsor
Jinling Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT04786743
Brief Title
Timing of Endoscopic Intervention for Acute Variceal Hemorrhage: an RCT
Acronym
TEACH
Official Title
Timing of Endoscopic Intervention in Patients With Cirrhosis With Acute Variceal Upper Gastrointestinal Hemorrhage (TEACH Trial): a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
February 15, 2024 (Anticipated)
Study Completion Date
February 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Acute variceal upper gastrointestinal hemorrhage remains a hot potato in cirrhotic patients. The purpose of this study is to figure out whether urgent endoscopy (within 6h after gastroenterological consultation) is superior to non-urgent endoscopy (between 6h and 24h after gastroenterological consultation) in reducing re-bleeding for these patients. This is a single-centered, prospective, randomized, and controlled trial. 400 patients with suspected variceal bleeding will be randomized in a 1:1 ratio to receive endoscopic intervention either within 6h or 6-24h. Randomization is conducted by permuted block randomization stratified by age, systolic blood pressure (SBP), and pulse rate. The primary efficacy endpoint is rebleeding within 42 days after control of acute variceal bleeding. This trial will provide valuable insights into the efficacy between the urgent endoscopy group and the non-urgent endoscopy group.
Detailed Description
Study design In this trial, we plan to conduct a single-centered, prospective, parallel-group randomized clinical trial. The study protocol observes the Standard Protocol Items rules: Recommendations for Interventional Trials (SPIRIT) 2013. The leader of the sponsoring organization strictly implements oversight of the protocol. We intend to compare the effectiveness of improving rebleeding rates of cirrhotic patients with acute variceal bleeding (AVB) between the urgent endoscopy and non-urgent endoscopy groups. Department of gastroenterology and hepatology, affiliated Jinling Hospital, Medical School of Nanjing University will take full charge of this trial, including recruitment of patients, endoscopic intervention, admission education, in-hospital nursing, subsequent follow-up work, etc. Informed consent forms from every patient will be signed before enrollment, and approval from the Ethical Committees of Jinling Hospital has been obtained (the final authorized ethic No. DZQH-KYLL-21-0101). Data processing Two investigators in our department are responsible for the data collection and storage. One investigator will inspect the data collected by the other investigator. After completing the inspection, the data, which are open to the analysts, will be kept in secret and input into the offline database constructed by the investigators. As soon as they complete all the data storage, the two investigators will conduct a double inspection. The collected data will be used for data analysis. The investigators will strictly follow the study protocol to inspect, collect, record and preserve the data in a timely manner to minimize the occurrence of missing data. If missing data occur in a small percentage of patients, we will handle it with multiple imputation. We will perform source data verification by comparing them with authentic medical records to assess the accuracy, completeness, and representativeness of registry data. Patients enrollment An estimated 400 patients will be consecutively included in the study between March 2021 and December 2023. Patients or their statutory agents must provide written, informed consent before participating in any of the study procedures. The model for end-stage liver disease (MELD) score, Child-Pugh score, cirrhosis acute gastrointestinal bleeding (CAGIB) score and original GBS, instead of the modified version22, will be used to evaluate the condition of each patient. Sample size According to a study by Ardevol A et al, among 646 cirrhotic patients with AVH who underwent endoscopy within 6 h after admission, the 45-day rebleeding rate was 26%, which was similar to that in another study by Chen PH et al, who reported that the overall 6-week rebleeding rate was 25.7%. Then, we assumed a clinically significant difference of 14% to implement this exploratory trial and provide support for further confirmatory trials. Next, we calculated that having at least 189 patients in each group would reveal differences (26% vs. 40%), with a statistical power of 80% and a two-sided α level of 5%. Considering withdrawal and loss to follow-up, the sample size was increased to 200 patients per group. Randomization and time set Eligible patients will be randomly assigned in a 1:1 ratio to receive endoscopic intervention either within 6 h or between 6 and 24 h after gastroenterological consultation. Randomization will be conducted by permuted block randomization stratified by age (≥60 y or <60 y), systolic blood pressure (SBP) (≥90 mmHg or <90 mmHg), and pulse rate (≥100 beats/min or <100 beats/min). The purpose of using stratified randomization is to reduce the imbalance of covariates because they are strongly correlated with the outcome indicators between groups, and to further control bias. The block size is prespecified, but physicians and investigators will not be notified of this fact during the study. The randomization sequence generation and allocation concealment will be implemented by the mobile client randomization tool "Randomization Allocation Tool (RAT)". There are two primary sources of patients. Most of these patients are from the emergency department, and the others are cirrhotic patients who developed AVH during hospitalization. For patients from the emergency department, the interval between admission and receiving gastroenterological consultation will be controlled within 10 minutes by applying the emergency green channel in our center. However, for patients who develop AVH during hospitalization, the time will be recorded according to when they are evaluated by the emergency endoscopy team (i.e., gastroenterological consultation). To facilitate data recording, the time will be uniformly calculated for all patients according to when the gastroenterological consultation is received. The patients will be randomly allocated to undergo urgent endoscopy within 6 h or nonurgent endoscopy between 6 h and 24 h after gastroenterological consultation. The following time data will be recorded: (I) time from presenting with symptoms of AVH to admission (patients from the emergency department); (II) time from admission to gastroenterological consultation (patients from the emergency department); (III) time from presentation to gastroenterological consultation (patients who develop AVH during hospitalization); and (IV) time from gastroenterological consultation to endoscopic intervention (all of the patients). Control of AVH, persistent bleeding, and rebleeding AVH under endoscopy mainly refers to blood gushing or seeping from esophageal or gastric varices; however, if there is no blood gush or seepage detected, thrombus stigmata attached to varices together with massive hematocele of the stomach will also be regarded as one kind of AVH under endoscopy. Control of AVH refers to a lack of persistent bleeding signs within 24 h after the initial endoscopic intervention; otherwise, the patients will be regarded as having persistent bleeding, which is defined as the occurrence of at least one of the following items: (I) vomiting of fresh blood or suction of more than 100 ml of fresh blood from the nasogastric tube; (II) occurrence of hemorrhagic shock; and (III) decrease in hemoglobin level of 30 g/L in the absence of a blood transfusion. Rebleeding refers to recurrent bleeding after the control of AVH, which is defined as the occurrence of at least one of the following items: (I) hematemesis, melena or hematochezia; (II) decrease in SBP of more than 20 mmHg from the original level or an increase in heart rate of 20 beats/min; and (III) decrease in hemoglobin level of 30 g/L in the absence of a blood transfusion. Patients with persistent bleeding or rebleeding will immediately undergo a secondary endoscopic intervention or be transferred for other salvage treatment (surgery, percutaneous transhepatic variceal embolization [PTVE] or transjugular intrahepatic portosystemic stent shunt [TIPSS]) according to the their condition and wishes. Although the vast majority of acute hemorrhage and rebleeding is caused by esophagogastric varices in this trial, acute hemorrhage and rebleeding caused by non-variceal factors will also be recorded and included in the statistical analysis. Treatment (I) Before endoscopic intervention: all patients will receive uninterrupted intravenous administration of high-dose PPIs (8 mg/h) and somatostatin (250 μg/h) and antibiotic prophylaxis; (II) Initial endoscopic intervention: patients who have nonvariceal bleeding under endoscopy will not be excluded from this trial; as patients are screened strictly according to the inclusion and exclusion criteria, there will theoretically not be many of these patients. Moreover, professional academic statisticians will conduct intent-to-treat analysis and per-protocol analysis, which are described in detail in the following statistical analysis. For patients meeting the criteria for AVH, numerous methods could be applied, including histoacryl injection, sclerotherapy, variceal ligation, a covered stent or combinations of these. The patient's position will be chosen to expose the best field of view under endoscopy, and an external cannula for endoscopy could be used to prevent asphyxiation. Furthermore, initial endoscopic intervention will be aimed solely at the bleeding site. After endoscopic intervention, we will transfer the patient to the general ward or intensive care unit (ICU) according to the patient's condition; (III) After the initial endoscopic intervention: all the patients will be treated with continuous high-dose PPIs (8 mg/h) and intravenous infusion of somatostatin (250 μg/h) for 72 h, together with the preventive administration of antibiotics for no more than 120 h; during the follow-up, oral propranolol and ultrasound-guided histoacryl injection could be used as secondary preventive measures according to the patient's condition. (IV) The emergency endoscopy team consists of three experienced endoscopists, each with more than ten years of experience in endoscopy and over 500 cases of variceal hemostasis experience under endoscopy. Furthermore, several seasoned endoscopic nurses who are proficient in applying endoscopic treatment instruments and cooperating with endoscopists will also be included. Follow-up time After randomization, follow-up work will begin. All the patients included will be followed up for no less than 42 days after controlling for AVH. When the patients' conditions are stable, further treatment of varices will be determined according to their wishes and statutory agents. Patients with good compliance will be administered standard endoscopic secondary prophylaxis after 5 days of AVH control, and the follow-up time should be once a week. Patients who decline to accept further endoscopic intervention will undergo only weekly follow-up. Follow-up could be in the form of a telephone or outpatient review. Follow-up will be regarded as complete at the time of death or in accordance with the follow-up deadline. Statistical analysis Primary analyses for the primary efficacy endpoint between the urgent endoscopy and nonurgent endoscopy groups will be performed in the intention-to-treat population, which will include all patients who are randomized to a study therapy group, regardless of whether they receive the endoscopic intervention. Multiple imputations with the Markov chain Monte Carlo method will be applied to impute the missing endpoints. Secondary analyses will be based on the per-protocol population, which will include all patients who receive the intended endoscopic intervention without a major protocol violation or loss to follow-up. Descriptive statistics will be used to compare patients randomized to the urgent endoscopy and nonurgent endoscopy groups with respect to baseline variables. Continuous variables will be expressed as the means and standard deviations (normally distributed) or medians and interquartile ranges (nonnormally distributed). Assessments of normality for continuous variables will be performed using the Shapiro-Wilk test. Categorical variables will be calculated as frequencies and percentages. For the primary analyses, the rebleeding rates within 42 days will be compared between the two groups using the chi-square tests and the Cochran-Mantel-Haenszel tests, and their differences and corresponding 95% confidence intervals (CIs) will be calculated. Additionally, the rebleeding rates will be estimated using the Kaplan-Meier method. The log-rank test will be used to compare the difference in rebleeding rates between the two groups. A Cox proportional hazards regression model will be used to estimate the hazard ratio (HR) and its 95% CI. The proportional hazards assumption will be assessed using the Schoenfeld residual test. Furthermore, the Cox regression model will be performed to assess the consistency of the endoscopy regarding the primary efficacy endpoint, taking the randomization stratification factor into consideration. Except for age, SBP, and pulse rate, the subgroup analysis also included sex, CAGIB score, the severity of liver disease, etc. For these subgroup analyses, HRs and 95% CIs for the primary efficacy endpoint will be calculated for each subgroup, and subgroup differences will be assessed based on the test for the interaction of the treatment group by subgroup in the model. Additionally, the Cox regression model will also be performed as a sensitivity analysis to assess the effect of endoscopy on the primary efficacy endpoint while accounting for a priori clinically important baseline characteristics (e.g., age, sex, CAGIB score, Child-Pugh score, MELD score, etc.). Two-tailed p values will be used, and a p value < 0.05 will be indicative of statistical significance. The secondary efficacy endpoints will be assessed in the per-protocol population and compared between the two groups with chi-square test for differences in proportions and with Student's t test and Wilcoxon's rank-sum test for normally distributed and nonnormally distributed data, respectively. The results for secondary efficacy endpoints will also be presented with 95% CIs. As they will not be adjusted for multiplicity, findings for the analysis of secondary efficacy endpoints should be interpreted as exploratory. All analyses will be performed using SAS software (version 9.4; SAS Institute, Cary, NC).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Upper Gastrointestinal Hemorrhage, Cirrhosis, Varice Bleed, Gastroesophageal Varices
Keywords
Endoscopic intervention; Acute variceal hemorrhage; RCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Eligible patients are randomly assigned in a 1:1 ratio to receive endoscopic intervention either within 6h or 6-24h. Randomization is conducted by permuted block randomization stratified by age, systolic blood pressure (SBP), and pulse rate. The block size is pre-specified, but physicians and investigators are not notified of this during the study. Allocation concealment is implemented by the mobile client randomization tool "Randomization Allocation Tool (RAT)".
Masking
Outcomes Assessor
Masking Description
The outcome assessors will be blinded to the randomization allocation and will not participate in the practical treatment and intervention; in particular, two scientific researchers specializing in gastroenterology with more than three years of clinical rotation experience will serve as the outcome assessors. Professional academic statisticians blinded to the group allocation will conduct all the analyses. However, the endoscopists will not participate in the outcome assessment. Furthermore, they will not need to disclose details of their interventional procedures to the outcome assessors.
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
non-urgent endoscopy group
Arm Type
Experimental
Arm Description
undergo endoscopy between 6 and 24 hours after gastroenterological consultation
Arm Title
urgent endoscopy group
Arm Type
Other
Arm Description
undergo endoscopy within 6 hours after gastroenterological consultation
Intervention Type
Other
Intervention Name(s)
endoscopic intervention
Other Intervention Name(s)
drugs, transjugular intrahepatic portosystemic stent shunt (TIPSS), surgery
Intervention Description
performing endoscopy
Primary Outcome Measure Information:
Title
Rebleeding
Description
Rebleeding refers to recurrent bleeding after the control of AVH, which is defined as the occurrence of at least one of the following items: (I) hematemesis, melena or hematochezia; (II) decrease in SBP of more than 20 mmHg from the original level or an increase in heart rate of 20 beats/min; and (III) decrease in hemoglobin level of 30 g/L in the absence of a blood transfusion.
Time Frame
42 days
Secondary Outcome Measure Information:
Title
Mortality
Description
After undergoing randomization, mortality from any causes within 42 days after randomization will be recorded.
Time Frame
42 days
Title
Persistent bleeding
Description
Persistent bleeding refers to bleeding that can not be controlled after initial endoscopic intervention within 24h. Persistent bleeding are defined as follows (at least one item appears): (I) vomiting of fresh blood or suction of more than 100 ml of fresh blood from the nasogastric tube; (II) occurrence of hemorrhagic shock; and (III) decrease in hemoglobin level of 30 g/L in the absence of a blood transfusion.
Time Frame
1 day
Title
length of hospitalization
Description
To record how long the patients stay at the hospital.
Time Frame
42 days
Title
Transfers to the ICU
Description
To record whether the patients are transferred to ICU.
Time Frame
42 days
Title
Secondary endoscopic intervention
Description
To record the secondary endoscopic intervention because of rebleeding or persistent bleeding.
Time Frame
42 days
Title
Blood transfusion therapy
Description
To record any blood transfusion therapy.
Time Frame
42 days
Title
In-hospital costs
Description
To record all the in-hospital costs.
Time Frame
42 days
Title
Adverse events
Description
To record any adverse events that occur during the follow-up.
Time Frame
42 days
Title
Transfers to undergo TIPSS
Description
To record patients with persistent bleeding or re-bleeding transferred to undergo TIPSS.
Time Frame
42 days
Title
Transfers to undergo surgery
Description
To record patients with persistent bleeding or re-bleeding transferred to undergo surgery.
Time Frame
42 days
Title
Concurrent infection
Description
To record infection related to endoscopic intervention.
Time Frame
5 days
Title
The patient's position
Description
To record the patient's primary position during endoscopy.
Time Frame
1 day
Title
Application of external cannula for endoscopy
Description
The external cannula for endoscopy is used to prevent aspiration according to the patient's condition.
Time Frame
1 day
Title
Secondary prophylaxis
Description
To record application of secondary prophylaxis (such as endoscopic intervention, TIPSS and surgery) during the follow-up.
Time Frame
42 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (I) patients who have pathological or clinical and imaging evidence indicating a diagnosis of cirrhosis; (II) patients with clinical symptoms associated with AVH (hematemesis, melena or hematochezia) before admission or during hospitalization; (III) patients who are hemodynamically stable before or after initial fluid resuscitation. Exclusion Criteria: (I) pregnancy; (II) lactation; (III) less than 18 years; (IV) patients with a history of taking anticoagulant or antiplatelet drugs within 2 weeks prior to admission.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhuoxin Yang, M.D.
Phone
+8618761679906
Email
yzxbeyond@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fangyu Wang, M.D.
Organizational Affiliation
Jinling Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Jinling Hospital, Medical School of Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210093
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhuoxin Yang, M.D.
Phone
+8618761679906
Email
yzxbeyond@163.com
First Name & Middle Initial & Last Name & Degree
Fangyu Wang, M.D.
Phone
+8613515100636
Email
wangfy65@nju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No
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PubMed Identifier
23303884
Citation
Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
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PubMed Identifier
28714072
Citation
Ardevol A, Ibanez-Sanz G, Profitos J, Aracil C, Castellvi JM, Alvarado E, Cachero A, Horta D, Minana J, Gomez-Pastrana B, Pavel O, Duenas E, Casas M, Planella M, Castellote J, Villanueva C. Survival of patients with cirrhosis and acute peptic ulcer bleeding compared with variceal bleeding using current first-line therapies. Hepatology. 2018 Apr;67(4):1458-1471. doi: 10.1002/hep.29370. Epub 2018 Feb 18.
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Timing of Endoscopic Intervention for Acute Variceal Hemorrhage: an RCT

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