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Development and research of clinical plan for domestic argon high-frequency electrosurgical instrument in the new diagnosis and treatment technology of digestive endoscopy

Development and research of clinical plan for domestic argon high-frequency electrosurgical instrument in the new diagnosis and treatment technology of digestive endoscopy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026860
Enrollment
Unknown
Registered
2019-10-24
Start date
2017-07-01
Completion date
Unknown
Last updated
2019-10-28

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

Conditions

Gastrointestinal disease

Interventions

Domestic electric knife:Using a domestic electric knife for surgery
Imported electric knife:Using an imported electric knife for surgery

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who were diagnosed with gastrointestinal mucosal lesions, submucosal lesions, and certain celiac diseases who were likely to undergo ESD, POEM, STER, and NOTES were fully evaluated. STER: submucosal lesions with esophagus and cardia and diameter <5 cm; subcutaneous submucosal lesions with a small curved side of the corpus, large curved side of the antrum, and proximal gastric cardia and corpus corpus diameter <3.5 cm; rectal diameter <3.5 cm Submucosal lesions. POEM: achalasia, diffuse esophageal fistula, nutcracker esophagus, the above diseases affect the quality of life. NOTES: The peritoneal masses NOTES (gastrointestinal gastrointestinal NOTES), the biliary and pancreatic diseases NOTES (biliary and pancreatic NOTES), and the gastrointestinal full-thickness disease NOTES (full-thickness NOTES) can be evaluated by NOTES. ESD: esophageal, gastric (upper digestive tract) and colorectal (lower digestive tract) mucosal or submucosal superficial lesions requiring endoscopic resection; endoscopic mucosal resection can not completely remove the lesion.

Exclusion criteria

Exclusion criteria: STER: severe submucosal fibrosis at the lesion can not successfully establish a submucosal tunnel, the lesions are obvious inflammation or huge ulcers; other: participated in other clinical trials in the past 3 months; pregnant lactating women; severe heart disease, lung disease; Mental disorders can not cooperate; acute severe throat disease, corrosive esophagitis, gastritis in the acute phase can not be gastroscope; esophagus, stomach, duodenal perforation can not be performed in the acute phase; blood disease, coagulopathy and taking anticoagulants In patients with coagulation, the coagulation function was not corrected; those who were allergic to the narcotic analgesics used; the investigators believed that there were any other conditions that were not suitable for the clinical trial. POEM: severe fibrosis of the lower esophageal mucosa could not successfully establish submucosal tunnels, obvious inflammation or huge ulcers in the lower esophagus or gastroesophageal junction; other STER regimen. NOTES: Surgical approach to the submucosal severe fibrosis can not successfully establish submucosal tunnels, obvious inflammation or huge ulcers; other with the STER program. ESD: esophageal, gastric (upper digestive tract) and colorectal (lower digestive tract) mucosal or submucosal lesions involving 2/3 of the submucosal lesions and below; other STER regimens. Exclusion: 1. There is no indication of contraindications or contraindications in the examination; 2. The patient insists on withdrawing from the trial; 3. Serious adverse events; 4. Other diseases that may affect the treatment outcome; 5. The investigator believes that there is reason to withdraw Other circumstances.

Design outcomes

Primary

MeasureTime frame
Bleeding (intraoperative and delayed bleeding);

Secondary

MeasureTime frame
perforation;infection;emphysema;pneumothorax;pneumoperitoneum;Pleural effusion;bellyache;Bloating;

Countries

China

Contacts

Public ContactBing Hu

West China Hospital, Sichuan University

hubingnj@163.com+86 18980601278

Outcome results

None listed

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