Patient ComplianceNCT06092281
Effect of Questionnaires and Feedback on the Patient Compliance for Endoscopic Surveillance After ESD
A study testing Questionnaire and Questionnaire without compliance-related education in people with Patient Compliance, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Patient Compliance
- What is being tested?
- Questionnaire and Questionnaire without compliance-related education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years) after ESD for mucosal lesions.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital of Digestive Disease
Xi'an, Shaanxi, 710032
Zhiguo Liu, 86-29-84771535, liuzhiguo@fmmu.edu.cn
Zhiguo Liu
About this study
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.
Read more
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.
Read the detailed description
This is a prospective, randomized controlled, superiority trial. The study population consists of patients after ESD for mucosal lesions at Xijing Hospital. In the control arm, patients after ESD are informed on follow-up instructions by doctors about the follow-up requirements before discharge, and complete a questionnaire without compliance-related education. In the questionnaire arm, in addition to receiving the same follow-up instructions as the control arm, patients need to complete a questionnaire on compliance-related education before discharge. Based on the responses, nurses provide feedback and guidance. Patients and doctors will be blind to the group of patients during the trial process. Our objective is 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.
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 1 will be expected to include 220 post-ESD patients randomized 1:1 into the questionnaire arm and control arm. Sample size calculation is based on short-term compliance data from a pilot trial, with a 20% difference between the two groups. Under the conditions of an α error of 5% (in a one-sided test) and power of 80%, assuming a superiority margin of 5%, a sample size of 220 cases is required.
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. Part 2 will be expected to include 500 post-ESD patients randomized 1:1 into the questionnaire arm and control arm. Under the conditions of an α error of 5% (in a one-sided test) and power of 80%, assuming a 20% difference between the two groups in long-term compliance outcome, a superiority margin of 10%, and rounding up, a sample size of 500 cases is required.
- Conditions
- Patient Compliance
- Being tested
- Questionnaire, Questionnaire without compliance-related education
- Keywords
- compliance, endoscopic submucosal dissection, surveillance, post-ESD
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Patients after ESD need to complete a questionnaire on compliance-related education before discharge. The questionnaire includes the following information:
- 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.)
- 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.)
- Awareness of the disease (self-perceived tumor is benign or malignant, whether lifestyle changes are required, etc.)
Questionnaire without compliance-related educationBehavioural
Patients 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.)
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Experimental | Patients after ESD are informed on follow-up instructions by doctors about the follow-up requirements before discharge, and complete a questionnaire without compliance-related education. Receives: Behavioral: Questionnaire without compliance-related education |
| Questionnaire Arm | Experimental | In addition to receiving the same follow-up instructions as the control group, patients need to complete a questionnaire on compliance-related education before discharge. Based on the responses, nurses provide feedback and guidance. Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of the first endoscopic surveillance (3 months)
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.
Measured: From enrollment to the end of the last endoscopic surveillance (1-5 years)
Secondary outcomes (6)
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.
Measured: From enrollment to the end of the first endoscopic surveillance (3 months)
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.
Measured: From enrollment to the end of the first endoscopic surveillance (3 months)
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.
Measured: Up to 5 years
Part 2: Incidence of local recurrence
Percentage of patients with local recurrence detected during follow-up
Measured: Up to 5 years
Part 2: Overall survival rate
Percentage of people still alive at 5 years after ESD
Measured: 5 years
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.
Measured: From enrollment to the end of the last endoscopic surveillance (1-5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Oct 2023
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Patient ComplianceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiguo Liu, Xijing Hospital of Digestive Diseases
- Investigators
- Zhiguo Liu, Principal investigator, Xijing Hospital of Digestive DIsease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092281
- Sponsor's protocol ID
- KY20232292-F-1
- Status last verified
- Aug 2026
- First submitted
- 6 Oct 2023
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33107115Tanaka 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.
PubMed 31566804Ishihara 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.
PubMed 32072683Pimentel-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.
PubMed 35523224
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Questionnaires and Feedback on the Patient Compliance for Endoscopic Surveillance After Endoscopic Submucosal Dissection: a Prospective, Randomized Controlled, Superiority Trial.
- ClinicalTrials.gov ID
- NCT06092281
- Acronym / sponsor ID
- KY20232292-F-1
- Conditions
- Patient Compliance
- Keywords
- compliance, endoscopic submucosal dissection, surveillance, post-ESD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, randomized controlled, superiority trial. The study population consists of patients after ESD for mucosal lesions at Xijing Hospital. In the control arm, patients after ESD are informed on follow-up instructions by doctors about the follow-up requirements before discharge, and complete a questionnaire without compliance-related education. In the questionnaire arm, in addition to receiving the same follow-up instructions as the control arm, patients need to complete a questionnaire on compliance-related education before discharge. Based on the responses, nurses provide feedback and guidance. Patients and doctors will be blind to the group of patients during the trial process. Our objective is 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.
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 1 will be expected to include 220 post-ESD patients randomized 1:1 into the questionnaire arm and control arm. Sample size calculation is based on short-term compliance data from a pilot trial, with a 20% difference between the two groups. Under the conditions of an α error of 5% (in a one-sided test) and power of 80%, assuming a superiority margin of 5%, a sample size of 220 cases is required.
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. Part 2 will be expected to include 500 post-ESD patients randomized 1:1 into the questionnaire arm and control arm. Under the conditions of an α error of 5% (in a one-sided test) and power of 80%, assuming a 20% difference between the two groups in long-term compliance outcome, a superiority margin of 10%, and rounding up, a sample size of 500 cases is required.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Experimental | Behavioral: Questionnaire without compliance-related educationPatients after ESD are informed on follow-up instructions by doctors about the follow-up requirements before discharge, and complete a questionnaire without compliance-related education. |
| Questionnaire Arm | Experimental | Behavioral: QuestionnaireIn addition to receiving the same follow-up instructions as the control group, patients need to complete a questionnaire on compliance-related education before discharge. Based on the responses, nurses provide feedback and guidance. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (≥18 years) after ESD for mucosal lesions.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairePatients 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.) | Behavioural | Questionnaire Arm |
| Questionnaire without compliance-related educationPatients 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.) | Behavioural | Control Arm |
Primary outcome
Part 1: short-term endoscopic surveillance compliance
Time frame: From enrollment to the end of the first endoscopic surveillance (3 months)
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
Time frame: From enrollment to the end of the last endoscopic surveillance (1-5 years)
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.
6 secondary outcomes
Part 1: Ulcer scar rate
Time frame: From enrollment to the end of the first endoscopic surveillance (3 months)
Part 1: Correlated Factors for short-term endoscopic surveillance compliance
Time frame: From enrollment to the end of the first endoscopic surveillance (3 months)
Part 2: Incidence of metachronous lesions
Time frame: Up to 5 years
Part 2: Incidence of local recurrence
Time frame: Up to 5 years
Part 2: Overall survival rate
Time frame: 5 years
Part 2: Correlated Factors for long-term endoscopic surveillance compliance
Time frame: From enrollment to the end of the last endoscopic surveillance (1-5 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Background: PubMed 33107115Ono 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.
- Background: PubMed 31566804Tanaka 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.
- Background: PubMed 32072683Ishihara 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.
- Background: PubMed 35523224Pimentel-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhiguo Liu principal investigator
Xijing Hospital of Digestive DIsease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire and Questionnaire without compliance-related education in people with Patient Compliance, run by Xijing Hospital of Digestive Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhiguo Liu (86-29-84771535, liuzhiguo@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: short-term endoscopic surveillance compliance (time frame: From enrollment to the end of the first endoscopic surveillance (3 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06092281, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.