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Magnetic Resonance Imaging Plus Submucosal Injection in Submucosal Invasion Identification for the Differentiation of Early Rectal Tumors

Magnetic Resonance Imaging Plus Submucosal Injection in Submucosal Invasion Identification for the Differentiation of Early Rectal Tumors

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200058848
Enrollment
Unknown
Registered
2022-04-17
Start date
2021-06-01
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Early rectal tumor

Interventions

Gold Standard:Histology of the resected rectal lesion
Index test:The MRI scans of submucosally-injected rectal lesion

Sponsors

Sichuan University West China Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Participants were recruited from the inpatient Department of Gastroenterology & Hepatology, West China Hospital. Eligible patients were: 1. Referred for endoscopic treatment of resectable rectal tumor (RT); 2. Aged 18 and over; 3. Were able to adhere to the protocol and give informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients received any preoperative RT-associated therapy, such as local excision and chemoradiotherapy; 2. Patients not suitable for endoscopic treatment (involving or exceeding the deep submucosal layer); 3. Pregnancy or lactation; 4. Unstable vital signs; 5. Severe concurrent diseases or malignancy; 6. MRI or endoscopy contradictions.

Design outcomes

Primary

MeasureTime frame
The accuracy of submucosal invasion identified by MRI;

Secondary

MeasureTime frame
The sensitivity of submucosal invasion identified by MRI;The specificity of submucosal invasion identified by MRI;The area under the ROC curve of submucosal invasion identified by MRI;

Countries

China

Contacts

Public ContactKai Deng

Sichuan University West China Hospital

dengkai@wchscu.cn+86 1822451156

Outcome results

None listed

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