Endoscopic submucosal dissection (ESD) is now considered the standard treatment for early gastrointestinal neoplasms. However, there is still a possibility of developing local recurrence or metachronous neoplasia after ESD. Regular endoscopic surveillance after ESD can identify and remove local recurrences and metachronous lesions early, improving patient prognosis. However, the patient compliance with post-ESD endoscopic surveillance is currently unclear, and many patients fail to adhere to the scheduled follow-up. A prospective, randomized controlled, superiority trial was designed to evaluate whether completing a questionnaire and receiving feedback on compliance-related education can improve patient compliance with post-ESD endoscopic surveillance, in comparison to those who did not complete the compliance-related education questionnaire. Additionally, the investigators intend to investigate the factors that influence patient compliance.
This study will consist of two parts.
Part 1 will assess whether the completion of questionnaire and feedback on compliance-related education can improve short-term patient compliance with post-ESD endoscopic surveillance, and investigate factors influencing short-term patient compliance.
Part 2 will assess whether the completion of questionnaire and feedback on compliance-related education can improve long-term patient compliance with post-ESD endoscopic surveillance, and investigate factors influencing patient compliance.
Adult patients (≥18 years) after ESD for mucosal lesions.
Patients after ESD for submucosal tumors, e.g. stromal tumors, neuroendocrine tumors;
Additional radical surgery after ESD procedure;
Past history of ESD procedure or local recurrence;
Severe comorbidities with a life expectancy of <6 months as judged by the investigator;
Parallel
Questionnaire
BehavioralPatients after ESD need to complete a questionnaire on compliance-related education before discharge. The questionnaire includes the following information: 1. General information about the patient (e.g., education level, place of residence, economic status, employment status, family history of neoplasms, whether the patient or immediate family member has a medical background, number of previous endoscopic examinations, etc.) 2. Awareness of follow-up examinations (e.g., knowledge about the timing of the first follow-up, the process of follow-up examinations, related educational issues about follow-up, etc.) 3. Awareness of the disease (self-perceived tumor is benign or malignant, whether lifestyle changes are required, etc.)
Questionnaire without compliance-related education
BehavioralPatients after ESD need to complete a questionnaire without compliance-related education before discharge. The questionnaire includes only general information about the patient (e.g., education level, place of residence, economic status, employment status, family history of neoplasms, whether the patient or immediate family member has a medical background, number of previous endoscopic examinations, etc.)
Part 1: short-term endoscopic surveillance compliance
Patients who undergo their first endoscopic surveillance within 3 months after ESD are considered to have good compliance, otherwise they are considered to have poor compliance.
Part 2: long-term endoscopic surveillance compliance
The criteria for endoscopic surveillance after ESD in this study are as follows: (1) For patients with non-neoplastic lesions and benign tumors after ESD, a follow-up of at least 1 year is required; (2) For patients with low-grade intraepithelial neoplasia and adenoma after ESD, a follow-up of at least 1 year is required; (3) For patients with high-grade intraepithelial neoplasia, a follow-up of at least 3 years is required, with an interval not exceeding 2 years; (4) For patients with carcinoma, a follow-up of at least 5 years is required, with an interval not exceeding 2 years. The criteria for assessing the compliance of endoscopic surveillance in this study are as follows: Patients who undergo endoscopic surveillance according to the above-mentioned criteria are considered to have good compliance, otherwise they are considered to have poor compliance.
Part 1: Ulcer scar rate
Percentage of people with ulcer scar stage at first endoscopic surveillance after ESD. The investigators will evaluate ulcer scar rates using a gastric ulcer staging system and measure the ulcer size.
Part 1: Correlated Factors for short-term endoscopic surveillance compliance
The short-term endoscopic surveillance compliance may be influenced by other factors. Patients who undergo their first endoscopic surveillance within 3 months after ESD are considered to have good compliance, otherwise they are considered to have poor compliance. First, univariate analysis will be used to identify potential factors influencing short-term endoscopic surveillance compliance. Then, all possible factors will be included in multivariate analysis.
Part 2: Incidence of metachronous lesions
Metachronous lesions are defined as lesions diagnosed at a minimum interval of 6 months after the initial neoplasia, and the location and pathological type of the lesion are different from the initial neoplasia.
Part 2: Incidence of local recurrence
Percentage of patients with local recurrence detected during follow-up
Click on the lead sponsor to view all of their trials.
