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Application of a novel traction device in endoscopic submucosal dissection for early gastric cancer and precancerous lesion - a multicenter, prospective, randomized controlled clinical trail

Application of a novel traction device in endoscopic submucosal dissection for early gastric cancer and precancerous lesion - a multicenter, prospective, randomized controlled clinical trail

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093892
Enrollment
Unknown
Registered
2024-12-13
Start date
2025-01-01
Completion date
Unknown
Last updated
2024-12-16

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

Conditions

Early gastric cancer and precancerous lesion

Interventions

Sponsors

The Second Hospital & Clinical Medical School,Lanzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1) Age 18 and above; (2) Early gastric cancer and precancerous lesion is diagnosed through magnifying endoscopy or staining endoscopy, and the tumor is located at the gastric fundus, gastric body, or gastric angle with a diameter of = 20mm; (3) The tumor meets the absolute and expanded indications of the Japanese Gastric Cancer Treatment Protocol (Second Edition): a. Differentiated adenocarcinoma within the mucosal layer, without ulcers; b. Differentiated adenocarcinoma within the mucosal layer of combined ulcers, = 30mm; (4) Preoperative pathological biopsy diagnosis is consistent with gastric cancer group subtypes 3, 4, and 5; (5) Patient activity status ECOG score 0-2.

Exclusion criteria

Exclusion criteria: (1) Preoperative diagnosis of early gastric cancer patients with invasion depth reaching the submucosal deep layer (= SM2); (2) Enhanced CT scan of the abdomen revealed lymph node metastasis; (3) Cases of local recurrence after endoscopic resection; (4) Patients with active malignant tumors outside the stomach; (5) Severe anemia, coagulation dysfunction, heart, lung, liver, and kidney dysfunction, severe acute infection, and pregnant patients; (6) Unable to tolerate intravenous anesthesia cases; (7) Anticoagulants and anticoagulants (excluding low-dose aspirin) cannot be discontinued; (8) Patients who are currently participating in other clinical studies.

Design outcomes

Primary

MeasureTime frame
Dissection speed;

Secondary

MeasureTime frame
Dissection duration;Muscle layer injury;The total amount of fluid injected under the mucosa;Intraoperative perforation;

Countries

China

Contacts

Public ContactPENGFEI WANG

The Second Hospital & Clinical Medical School, Lanzhou University

wpfw@foxmail.com+86 181 5367 3602

Outcome results

None listed

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