Clinical trial · Interventional
The Diagnosis of Invasive Depth of Early Rectal Cancer
A Randomized Controlled Clinical Study on the Accuracy of Linear Endoscopic Ultrasonography and Magnifying Narrowband Endoscopy in the Diagnosis of Invasive Depth of Early Rectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this clinical study is to compare the accuracy of linear endoscopic ultrasonography and magnified narrowband endoscopy in the diagnosis of invasive depth of early rectal cancer, and to provide more powerful evidence for the choice of surgical methods for early rectal cancer. Patients with early rectal cancer who will be examined by endoscopic ultrasonography or magnifying narrowband endoscopy in the department of gastroenterology and general surgery will be examined by linear endoscopic ultrasonography or magnifying narrowband endoscopy to examine the depth of invasion of early rectal cancer, and the results are compared with the postoperative pathological results of the patients as the gold standard. It provides strong evidence that the accuracy of linear endoscopic ultrasonography in judging the invasive depth of early colorectal cancer is not inferior to that of magnifying narrowband endoscopy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Rectal Cancer | Rectal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Linear EUS first | Diagnostic Test | — | UNRESOLVED |
| ME-NBI first | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Linear EUS
- description
- patients underwent linear endoscopic ultrasonography followed by magnifying narrowband endoscopy
- interventionNames
- Diagnostic Test: Linear EUS first
- type
- EXPERIMENTAL
- label
- ME-NBI
- description
- patients underwent magnifying narrowband endoscopy followed by linear endoscopic ultrasonography
- interventionNames
- Diagnostic Test: ME-NBI first
Primary outcomes (1)
- measure
- Diagnostic accuracy
- timeFrame
- through study completion, an average of 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Colonoscopic diagnosis of early rectal cancer, the longest diameter \>10mm. 2. Age 18 Mel 80 years old; 3. The subjects are willing to participate in this clinical trial and sign the relevant informed consent form. Exclusion Criteria: 1. The coagulation function of the subjects was abnormal and uncontrolled: international standardized ratio ((INR))\>2 or platelet count \<75000 platelets / μ L; 2. Three months before entering the group, there were uncontrolled angina pectoris and / or myocardial infarction, congestive heart failure, lung (respiratory failure), kidney, pancreas, liver disease or other diseases were judged by the researchers to be unable to participate in the study. 3. Pregnant woman
References
Publications (1)
- DERIVEDLi L, He J, Hu H, Wang Y, Li W, Huang S, Rownoak J, Xu S, Xie F, Wang J, Mi W, Cai J, Ye Y, Liu S, Wang J, Li Y. Linear-Array Endoscopic Ultrasound and Narrow-Band Imaging Measure the Invasion Depth of Nonpedunculated Rectal Lesions With Comparable Accuracy Based on a Randomized Controlled Trial. Am J Gastroenterol. 2025 Mar 1;120(3):562-569. doi: 10.14309/ajg.0000000000002975. Epub 2024 Jul 25. PMID 39051647