Patient Compliance Clinical Trial
Official title:
Effect of Questionnaires and Feedback on the Patient Compliance for Endoscopic Surveillance After Endoscopic Submucosal Dissection: a Prospective, Randomized Controlled, Superiority Trial.
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | December 2029 |
Est. primary completion date | December 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Adult patients (=18 years) after ESD for mucosal lesions. Exclusion Criteria: - 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; - Unable to cooperate with information collection due to mental disorders, severe neurosis, or dysgnosia; - Unable to understand or unwilling to sign a written informed consent. |
Country | Name | City | State |
---|---|---|---|
China | Xijing Hospital of Digestive Disease | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
Xijing Hospital of Digestive Diseases |
China,
Ishihara R, Arima M, Iizuka T, Oyama T, Katada C, Kato M, Goda K, Goto O, Tanaka K, Yano T, Yoshinaga S, Muto M, Kawakubo H, Fujishiro M, Yoshida M, Fujimoto K, Tajiri H, Inoue H; Japan Gastroenterological Endoscopy Society Guidelines Committee of ESD/EMR for Esophageal Cancer. Endoscopic submucosal dissection/endoscopic mucosal resection guidelines for esophageal cancer. Dig Endosc. 2020 May;32(4):452-493. doi: 10.1111/den.13654. — View Citation
Ono H, Yao K, Fujishiro M, Oda I, Uedo N, Nimura S, Yahagi N, Iishi H, Oka M, Ajioka Y, Fujimoto K. Guidelines for endoscopic submucosal dissection and endoscopic mucosal resection for early gastric cancer (second edition). Dig Endosc. 2021 Jan;33(1):4-20. doi: 10.1111/den.13883. Epub 2020 Dec 9. — View Citation
Pimentel-Nunes P, Libanio D, Bastiaansen BAJ, Bhandari P, Bisschops R, Bourke MJ, Esposito G, Lemmers A, Maselli R, Messmann H, Pech O, Pioche M, Vieth M, Weusten BLAM, van Hooft JE, Deprez PH, Dinis-Ribeiro M. Endoscopic submucosal dissection for superficial gastrointestinal lesions: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2022. Endoscopy. 2022 Jun;54(6):591-622. doi: 10.1055/a-1811-7025. Epub 2022 May 6. — View Citation
Tanaka S, Kashida H, Saito Y, Yahagi N, Yamano H, Saito S, Hisabe T, Yao T, Watanabe M, Yoshida M, Saitoh Y, Tsuruta O, Sugihara KI, Igarashi M, Toyonaga T, Ajioka Y, Kusunoki M, Koike K, Fujimoto K, Tajiri H. Japan Gastroenterological Endoscopy Society guidelines for colorectal endoscopic submucosal dissection/endoscopic mucosal resection. Dig Endosc. 2020 Jan;32(2):219-239. doi: 10.1111/den.13545. Epub 2019 Dec 27. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | From enrollment to the end of the first endoscopic surveillance (3 months) | |
Primary | 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. | From enrollment to the end of the last endoscopic surveillance (1-5 years) | |
Secondary | 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. | From enrollment to the end of the first endoscopic surveillance (3 months) | |
Secondary | 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. | From enrollment to the end of the first endoscopic surveillance (3 months) | |
Secondary | 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. | Up to 5 years | |
Secondary | Part 2: Incidence of local recurrence | Percentage of patients with local recurrence detected during follow-up | Up to 5 years | |
Secondary | Part 2: Overall survival rate | Percentage of people still alive at 5 years after ESD | 5 years | |
Secondary | Part 2: Correlated Factors for long-term endoscopic surveillance compliance | The long-term endoscopic surveillance compliance may be influenced by other factors. Patients who undergo endoscopic surveillance according to the above-mentioned criteria (see Outcome 2) 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 long-term endoscopic surveillance compliance. Then, all possible factors will be included in multivariate analysis. | From enrollment to the end of the last endoscopic surveillance (1-5 years) |
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