Timing of Endoscopic Intervention in Patients With Cirrhosis With Acute Variceal Upper Gastrointestinal Hemorrhage (TEACH Trial): a Randomized Clinical Trial

Study design

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 hemorrhage (AVH) between the urgent endoscopy and non-urgent endoscopy groups. The study started on April 20, 2021, and was initially designed as a single-center study. However, due to the impact of the COVID-19, case enrollment was greatly challenged, and our study was put on hold for about 8 months. To ensure the smooth progress of this study, we submitted the application for adding the participating centers to the Ethics Committee of affiliated Jinling Hospital, Medical School of Nanjing University (the lead center) in April 2023, and in May, we received approval from Ethics Committee of Jinling hospital to add five participating centers. One year later, we submitted a request to the Hospital Ethics Committee to modify the participating centers, proposing the removal of one existing center and the addition of two new ones. This amendment received approval from the Ethics Committee. However, due to the shortage of patients with AVH, apart from the lead center, only three participating centers, ultimately participated in the study. These three participating centers were: The first affiliated Hospital of Nanjing Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, and The Affiliated Wuxi People's Hospital of Nanjing Medical University. In this study, we plan to conduct a multi-centered, prospective, parallel-group randomized clinical trial. Informed consent forms from every patient will be signed before enrollment, and approval from the Ethical Committees of Jinling Hospital has been obtained (the authorized ethics numbers were DZQH-KYLL-21-0101, 2023DZKY-031-01, and 2023DZKY-031-03). Furthermore, the study protocol was also approved by the ethics committees of each participating center.

Data processing

Two investigators in every 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