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A randomized controlled clinical study on UEMR treatment of superficial gastrointestinal lesions smaller than 2cm

A randomized controlled clinical study on UEMR treatment of superficial gastrointestinal lesions smaller than 2cm

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400089067
Enrollment
Unknown
Registered
2024-07-24
Start date
2024-01-03
Completion date
Unknown
Last updated
2024-09-02

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

Conditions

Superficial lesions of the digestive tract less than 2cm

Interventions

Observation group:UEMR resection group :none
Control group:ESD resection group:none

Sponsors

No. 12 Jiankang Road, Shijiazhuang City, Hebei Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Endoscopy examination indicates early gastrointestinal lesions (polyps, early cancer, etc.); 2. Before surgery, all lesions were assessed by magnification and/or endoscopic ultrasound (EUS), with invasion depth limited to the mucosal layer and submucosal layer; Average diameter<2cm 3. Three preoperative chest, abdominal, and pelvic CT and/or MR examinations showed no lymph nodes or distant metastases; 4. Imaging assisted diagnosis is considered as superficial lesions of the digestive tract; 5. Pathological results confirm polyps or early cancer, etc; 6. Sign informed consent form

Exclusion criteria

Exclusion criteria: 1. Concomitant serious diseases such as heart, lung, and kidney; 2. Pregnant and lactating women; 3. Abnormal coagulation function. 4. Low differentiated early cancer

Design outcomes

Primary

MeasureTime frame
Pathological diagnosis results of horizontal and vertical margins of excised specimens;Complication rate;

Secondary

MeasureTime frame
Bowel readiness;Endoscopic morphological classification of lesion location;Surgical time;Surgical expenses;

Countries

China

Contacts

Public ContactEr limian

Hebei Medical University Fourth Hospital

Hbsyelm@163.com+86 135 1337 9068

Outcome results

None listed

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