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Protocol for a randomized controlled clinical trial on the application of the water-filled method in minimally invasive endoscopic therapy.

Protocol for a randomized controlled clinical trial on the application of the water-filled method in minimally invasive endoscopic therapy.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099893
Enrollment
Unknown
Registered
2025-03-31
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal mucosal early cancer and submucosal masses

Interventions

Experimental group: Surgical operation was performed using the water filling method. :150:The water filling method is used for surgical procedures
Control group: Conventional gas filling method was used for surgical operation.:Surgical procedures are performed using the conventional gas filling method

Sponsors

The Fourth Affiliated Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: All inclusion criteria comply with the current diagnosis and treatment guidelines for specific diseases in China Endoscopic minimally invasive treatment surgery is divided into various surgical procedures, including endoscopic resection of esophageal, gastric, and colonic mucosal lesions, resection of gastric submucosal masses, and complete removal of intrinsic muscle layer masses, such as EMR, STER, and endoscopic full thickness resection (EFTR). All inclusion criteria comply with the current diagnosis and treatment guidelines for specific diseases in China. For example, the inclusion criteria for endoscopic submucosal dissection of the esophagus are: Esophageal lesions meet the clear diagnostic criteria for early esophageal cancer and precancerous lesions in the 2022 Chinese Guidelines for Screening, Early Diagnosis, and Early Treatment of Esophageal Cancer: Early esophageal cancer refers to invasive esophageal cancer with lesions limited to the mucosal layer, regardless of whether there is regional lymph node metastasis; Esophageal precancerous lesions include esophageal squamous epithelial cell dysplasia and Barrett's esophageal dysplasia. The extent of the lesions is less than 3/4 of the circumference of the esophagus; Confirmed through pathological and other relevant clinical examinations; For patients with pathological diagnosis of esophageal cancer, preoperative comprehensive endoscopic ultrasound evaluation of lesion invasion depth: Preoperative endoscopic ultrasound examination suggests that the lesion is limited to the esophageal mucosal layer, without invading the submucosal and muscular layers, or slightly infiltrating the submucosal layer (submucosal invasion depth of 200m); Tolerant general anesthesia and tracheal intubation anesthesia; All included researchers are aware of this study and have signed informed consent forms.

Exclusion criteria

Exclusion criteria: Patients with primary organ diseases such as heart, lung, liver, and brain 2: Patients with tumors in other tissues and organs besides the selected disease included 3: Individuals with coagulation dysfunction and hematological disorders.

Design outcomes

Primary

MeasureTime frame
Evaluation criteria for the operation method of water filling method;Surgical data, such as surgical time, postoperative complications, etc;

Countries

China

Contacts

Public ContactLiu Lu

Department of Gastroenterology, The Fourth Affiliated Hospital of China Medical University

liulucmu4@163.com+86 189 0091 2132

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026