Trial Title:
Cytosponge in Surveillance After Endoscopic Submucosal Dissection for Esophageal Squamous Cell Carcinoma
NCT ID:
NCT06429865
Condition:
Esophageal Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Conditions: Keywords:
Esophageal Squamous Cell Carcinoma
Cytosponge
Surveillance
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
cytosponge
Description:
Use of cytosponge as a tool to patients who need surveillance after endoscopic submucosal
dissection for esophageal squamous cell carcinoma
Arm group label:
esophageal squamous cell carcinoma group
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 people's 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 (39%~47%), 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 Barrett's esophagus showed that the sensitivity
of cytology combined with different biomarkers of the new cell collector of the esophagus
was 73.3% - 93.1%, and the specificity was 92.4-95.7%; It can play a good risk
stratification role in Barrett's 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 Barrett's 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 Barrett's
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 Barrett's esophagus with a circumference of 1cm or more were
73.3% and 93.8%, respectively. Similarly, a multicenter randomized controlled trial in
the UK in recent years also confirmed the diagnostic efficacy of cellular sponge capsule
in Barrett's 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 93.7% 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- (1) Sex unlimited, age 18-85; (2) The indication of ESD for early (superficial)
esophageal squamous cell carcinoma conforms to the domestic and foreign guidelines;
(3) The pathological stage of ESD was pT1a/pT1b.
Exclusion Criteria:
- (1) The pathological findings after ESD were HGIN; (2) Dysphagia (Stooler grade
2-4), inability to swallow cell sponge capsule successfully; (3) Postoperative
pathological data were incomplete; (4) Have a history of cancer, early cancer,
adenoma and other benign and malignant tumors of stomach and duodenum, combined with
malignant tumors of other parts; (5) Previous esophageal or gastric surgery; (6)
Esophagectomy, segmented endoscopic mucosal resection (EMR), multi ring mucosal
resection (MBM) and other endoscopic non block resection techniques were used; (7)
Those who have coagulation dysfunction or need to take anticoagulant and
antiplatelet drugs continuously; (8) There are contraindications to gastroscopy and
mucosal biopsy; (9) People with other serious diseases whose life expectancy is less
than 5 years; (10) I refuse to cooperate with the research scheme and refuse to sign
the informed consent form.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Changhai Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Start date:
May 2024
Completion date:
December 2024
Lead sponsor:
Agency:
Changhai Hospital
Agency class:
Other
Collaborator:
Agency:
Tongliao City Hospital
Agency class:
Other
Collaborator:
Agency:
Ankang Central Hospital
Agency class:
Other
Collaborator:
Agency:
Yancheng First People's Hospital
Agency class:
Other
Collaborator:
Agency:
Lianshui County People's Hospital
Agency class:
Other
Collaborator:
Agency:
Nanchong Central Hospital
Agency class:
Other
Collaborator:
Agency:
Henan Provincial People's Hospital
Agency class:
Other
Collaborator:
Agency:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Agency class:
Other
Collaborator:
Agency:
Zhongda Hospital
Agency class:
Other
Collaborator:
Agency:
Affiliated hospital of nanjing university hospital of Chinese medicine
Agency class:
Other
Source:
Changhai Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06429865
