Cytosponge in Surveillance After Endoscopic Submucosal Dissection for Esophageal Squamous Cell Carcinoma

NCT06429865 | Enrolling By Invitation DMC

• 1 other identifier: CTSESD-20220509
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

Esophageal Squamous Cell Carcinoma; Cytosponge; Surveillance

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy

  Sensitivity and Specificity

  60 minute

Study Arms (1)

esophageal squamous cell carcinoma group

EXPERIMENTAL

Participants were instructed to place the capsule near the root of the tongue and fold the string in their mouths, leaving approximately 20 cm of string outside, with a blue mark on the string right at the lips. The capsule was then swallowed with water, and the end of the string was held out of the mouth. Participants were then asked to slowly drink 150-200 mL of 50°C water in approximately 2 minutes to allow the capsule to dissolve so that the sponge mesh inside was released. The device was then slowly withdrawn up the esophagus by pulling the string. The retrieved and expanded cell collection material was put in preservative fluid (Froeasy Technology, Nanjing, China) and transferred to the cytology laboratory at room temperature.

Diagnostic Test: cytosponge

Interventions

cytosponge DIAGNOSTIC_TEST

Use of cytosponge as a tool to patients who need surveillance after endoscopic submucosal dissection for esophageal squamous cell carcinoma

esophageal squamous cell carcinoma group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Changhai Hospital: lead
• Tongliao City Hospital: collaborator
• Ankang Central Hospital: collaborator
• Yancheng First People's Hospital: collaborator
• Lianshui County People's Hospital: collaborator
• Nanchong Central Hospital: collaborator
• Henan Provincial People's Hospital: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• Zhongda Hospital: collaborator
• Affiliated hospital of nanjing university hospital of Chinese medicine: collaborator

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Luowei Wang, MD

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD; MD； Chief Physician

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: May 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)