Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429865
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-28
First Post:
2024-05-21
Brief Title:
Cytosponge in Surveillance After Endoscopic Submucosal Dissection for Esophageal Squamous Cell Carcinoma
Sponsor:
Changhai Hospital
Organization:
Changhai Hospital
Study Overview
Official Title:
Safety and Effectiveness of Cytosponge in Surveillance After Endoscopic Submucosal Dissection for Esophageal Squamous Cell Carcinoma
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
cytosponge has good diagnostic efficacy in the diagnosis of esophageal cancer and is more safe economic and comfortable It is expected to replace gastroscope in the surveillance after endoscopic submucosal dissection to a certain extent At present there is no relevant research at home and abroad This study plans to establish a large sample cohort based on the collaborative research network established earlier prospectively include 1000 patients who received endoscopic submucosal dissection for esophageal squamous cell carcinoma and compare the effectiveness and safety of cytosponge and gastroscope in surveillance after endoscopic submucosal dissection for esophageal squamous cell carcinoma through self -comparison
Detailed Description:
Esophageal cancer is one of the common malignant tumors in the world In 2020 the number of new cases of esophageal cancer in the world will reach 604000 and the number of deaths will reach 544000 As a high incidence area of esophageal cancer in China esophageal squamous cell carcinoma ESCC is the most common with about 324000 cases of morbidity and 301000 deaths each year posing a serious threat to peoples lives and health With the continuous development of digestive endoscopy technology endoscopic submucosal dissection ESD and other minimally invasive endoscopic techniques have become the first line of treatment for early esophageal cancer However studies have shown that there is a risk of local recurrence within one year after ESD for early esophageal cancer with a recurrence rate of 0-17 Therefore surveillance detection after ESD has become an important link in the diagnosis and treatment of esophageal cancer
At present there is no uniform standard at home and abroad for surveillance after ESD for esophageal squamous cell carcinoma no matter the frequency or method of surveillance For example the guidelines issued by Japan suggest that the surveillance should be conducted every 6 to 12 months after ESD at least once a year In the guidelines issued by the European Society of Gastroenterology it is recommended to review endoscopy 3 to 6 months after ESD If there is no recurrence it can be changed to review endoscopy once a year The Guidelines for the Diagnosis and Treatment of Esophageal Cancer issued by the National Health Commission in April 2022 suggests that patients should be rechecked 3 months 6 months and 12 months after ESD and if there is no recurrence they should be rechecked once a year Recheck once every three months within two years after surgery once every six months within two to five years and once every year after five years Although the above guidelines and specific strategies for surveillance after esophageal cancer surgery have not yet been unified the use of upper gastrointestinal endoscopy hereinafter referred to as gastroscope as the main means of review and close surveillance are more consistent
However due to the invasiveness cost and availability of gastroscope frequent endoscopic surveillance of patients with esophageal cancer after ESD may bring significant economic and health burden to patients and lead to a decline in patients subjective surveillance enthusiasm Therefore it is of great significance to find a more safe economical and comfortable surveillance method that is equivalent to the diagnostic performance of gastroscope for standardizing the surveillance after ESD for esophageal cancer
cytosponge is a new non-invasive examination method which can diagnose esophageal lesions by collecting esophageal cells and carrying out cytological examination and p53 staining Its diagnostic efficacy for esophageal cancer has been confirmed in various studies at home and abroad Esophageal cytology has been proved to have a good application prospect in the identification and screening of high-risk groups of esophageal cancer In the 20th century our country widely carried out esophageal mesh cytology for screening esophageal cancer in high incidence areas but this method has low sensitivity 3947 is easy to miss diagnosis and has poor inspection comfort and has been eliminated at present The improved new esophageal cell collectors such as CytospongeTM EsophaCapTM Shikang No 1 TM etc adopt the expanded sponge capsule design which increases the contact area with esophageal mucosa and has a higher success rate than the original dragnet cytology sampling Cytological examination is relatively simple Combining with the high-risk factor scoring scale can improve the screening effect and improve the positive rate and screening efficiency of surveillance endoscopic intensive examination Foreign studies on Barretts esophagus showed that the sensitivity of cytology combined with different biomarkers of the new cell collector of the esophagus was 733 - 931 and the specificity was 924-957 It can play a good risk stratification role in Barretts esophageal related dysplasia and early esophageal adenocarcinoma 0 in low-risk group 14 in medium risk group and 87 in high-risk group The diagnostic and management guidelines for Barretts esophagus formulated by the British Gastroenterological Association and the American Gastroenterological Society both point out that Cytosponge can be used as a screening method for Barretts esophagus and it is more in line with the principles of health economics As early as 2010 a prospective cohort study in the UK showed that the sensitivity and specificity of cytosponges in diagnosing Barretts esophagus with a circumference of 1cm or more were 733 and 938 respectively Similarly a multicenter randomized controlled trial in the UK in recent years also confirmed the diagnostic efficacy of cellular sponge capsule in Barretts esophagus In addition for areas with high incidence of ESCC a study based on the Golestan cohort in Iran pointed out that the accuracy of cytological examination combined with p53 staining in detecting high-grade esophageal squamous hyperplasia could reach 100 In a previous study conducted by our team 1844 subjects from high-risk areas of ESCC were recruited and the effectiveness safety and comfort of the two in esophageal cancer screening were compared through cytosponge examination and gastroscopy The results showed that the sensitivity and specificity of cellular sponge capsule in the diagnosis of high-grade esophageal lesions including esophageal squamous cell carcinoma and high-grade intraepithelial neoplasia were 90 and 937 respectively However no serious adverse events were recorded during cell collection which fully demonstrates the feasibility and safety of AI helper cytosponge in community screening of ESCC
To sum up the cellular sponge capsule has good diagnostic efficacy in the diagnosis of esophageal cancer and is more safe economical and comfortable It is expected to replace gastroscope in the surveillance after ESD to a certain extent At present there is no relevant research at home and abroad This study plans to establish a large sample cohort based on the collaborative research network established earlier prospectively include 1000 patients who received ESD resection treatment for early esophageal cancer and compare the effectiveness and safety of cytosponge and gastroscope in the surveillance of early esophageal cancer after ESD through self-comparison
At present there is no uniform standard at home and abroad for surveillance after ESD for esophageal squamous cell carcinoma no matter the frequency or method of surveillance For example the guidelines issued by Japan suggest that the surveillance should be conducted every 6 to 12 months after ESD at least once a year In the guidelines issued by the European Society of Gastroenterology it is recommended to review endoscopy 3 to 6 months after ESD If there is no recurrence it can be changed to review endoscopy once a year The Guidelines for the Diagnosis and Treatment of Esophageal Cancer issued by the National Health Commission in April 2022 suggests that patients should be rechecked 3 months 6 months and 12 months after ESD and if there is no recurrence they should be rechecked once a year Recheck once every three months within two years after surgery once every six months within two to five years and once every year after five years Although the above guidelines and specific strategies for surveillance after esophageal cancer surgery have not yet been unified the use of upper gastrointestinal endoscopy hereinafter referred to as gastroscope as the main means of review and close surveillance are more consistent
However due to the invasiveness cost and availability of gastroscope frequent endoscopic surveillance of patients with esophageal cancer after ESD may bring significant economic and health burden to patients and lead to a decline in patients subjective surveillance enthusiasm Therefore it is of great significance to find a more safe economical and comfortable surveillance method that is equivalent to the diagnostic performance of gastroscope for standardizing the surveillance after ESD for esophageal cancer
cytosponge is a new non-invasive examination method which can diagnose esophageal lesions by collecting esophageal cells and carrying out cytological examination and p53 staining Its diagnostic efficacy for esophageal cancer has been confirmed in various studies at home and abroad Esophageal cytology has been proved to have a good application prospect in the identification and screening of high-risk groups of esophageal cancer In the 20th century our country widely carried out esophageal mesh cytology for screening esophageal cancer in high incidence areas but this method has low sensitivity 3947 is easy to miss diagnosis and has poor inspection comfort and has been eliminated at present The improved new esophageal cell collectors such as CytospongeTM EsophaCapTM Shikang No 1 TM etc adopt the expanded sponge capsule design which increases the contact area with esophageal mucosa and has a higher success rate than the original dragnet cytology sampling Cytological examination is relatively simple Combining with the high-risk factor scoring scale can improve the screening effect and improve the positive rate and screening efficiency of surveillance endoscopic intensive examination Foreign studies on Barretts esophagus showed that the sensitivity of cytology combined with different biomarkers of the new cell collector of the esophagus was 733 - 931 and the specificity was 924-957 It can play a good risk stratification role in Barretts esophageal related dysplasia and early esophageal adenocarcinoma 0 in low-risk group 14 in medium risk group and 87 in high-risk group The diagnostic and management guidelines for Barretts esophagus formulated by the British Gastroenterological Association and the American Gastroenterological Society both point out that Cytosponge can be used as a screening method for Barretts esophagus and it is more in line with the principles of health economics As early as 2010 a prospective cohort study in the UK showed that the sensitivity and specificity of cytosponges in diagnosing Barretts esophagus with a circumference of 1cm or more were 733 and 938 respectively Similarly a multicenter randomized controlled trial in the UK in recent years also confirmed the diagnostic efficacy of cellular sponge capsule in Barretts esophagus In addition for areas with high incidence of ESCC a study based on the Golestan cohort in Iran pointed out that the accuracy of cytological examination combined with p53 staining in detecting high-grade esophageal squamous hyperplasia could reach 100 In a previous study conducted by our team 1844 subjects from high-risk areas of ESCC were recruited and the effectiveness safety and comfort of the two in esophageal cancer screening were compared through cytosponge examination and gastroscopy The results showed that the sensitivity and specificity of cellular sponge capsule in the diagnosis of high-grade esophageal lesions including esophageal squamous cell carcinoma and high-grade intraepithelial neoplasia were 90 and 937 respectively However no serious adverse events were recorded during cell collection which fully demonstrates the feasibility and safety of AI helper cytosponge in community screening of ESCC
To sum up the cellular sponge capsule has good diagnostic efficacy in the diagnosis of esophageal cancer and is more safe economical and comfortable It is expected to replace gastroscope in the surveillance after ESD to a certain extent At present there is no relevant research at home and abroad This study plans to establish a large sample cohort based on the collaborative research network established earlier prospectively include 1000 patients who received ESD resection treatment for early esophageal cancer and compare the effectiveness and safety of cytosponge and gastroscope in the surveillance of early esophageal cancer after ESD through self-comparison
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None