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| Name | Class |
|---|---|
| Guangdong Provincial Hospital of Traditional Chinese Medicine | OTHER |
| Guangdong Second Provincial General Hospital | OTHER |
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Conventional white-light endoscopy (WLE) is hampered by insufficient contrast when attempting to identify deep vessels and active bleeding sites; visibility drops further when blood pools or spurts obscure the field, resulting in significantly lower hemostatic efficiency. Red dichromatic imaging (RDI), a novel image-enhanced endoscopic modality, has recently been shown to improve the visualization of deep-lying vessels and bleeding points, shorten hemostasis time and potentially increase overall procedural efficiency.
Although retrospective series have suggested that RDI may facilitate intra-operative bleeding control and better delineation of the submucosal plane during endoscopic submucosal dissection (ESD), high-level evidence from multicenter, randomized, controlled trials (RCTs) is lacking. No study has yet demonstrated superiority over WLE with respect to critical endpoints such as en-bloc resection rate, procedure time, complication rate and operator mental workload.
The investigators therefore designed a multicenter RCT to systematically compare the efficacy and safety of full-procedural RDI with conventional WLE during ESD.
The primary outcome parameter is the mean resection speed (mm²/min) achieved with RDI versus conventional white-light endoscopy during ESD.
The secondary outcome parameters are: complete resection (R0) rate, en-bloc resection rate, resection margin, number of intra-procedural bleeding episodes, intra-procedural blood loss, intra-procedural hemostasis time, other intra-procedural adverse events, and post-procedural adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RDI group | Experimental | Throughout the entire ESD dissection, the RDI mode is used continuously for submucosal dissection (while white-light endoscopy may be employed for observation and marking). |
|
| WLE group | No Intervention | The WLE group completes the entire ESD procedure using only WLE, without switching to RDI. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RDI | Other | Throughout the entire ESD dissection, the RDI mode is used continuously for submucosal dissection (while white-light endoscopy may be employed for observation and marking). |
| Measure | Description | Time Frame |
|---|---|---|
| mean resection speed (mm²/min) achieved with RDI versus conventional WLE during ESD | The resection speed is calculated as the area on the specimen-fixation board divided by the time elapsed from the first mucosal incision to complete dissection of the lesion. | Periprocedural |
| Measure | Description | Time Frame |
|---|---|---|
| complete resection (R0) rate | complete resection (R0) rate | Periprocedural |
| en-bloc resection rate | en-bloc resection rate | Periprocedural |
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Inclusion Criteria:
Age ≥ 18 years.
Early gastric cancer or precancerous lesions, early esophageal cancer or precancerous lesions, or early colorectal cancer/polyps that meet ESD indications.
ESD procedure to be performed at a participating center.
Exclusion Criteria:
① Foreigners.
② Severe coagulopathy (platelet count <50×10⁹/L or INR >1.5), significant cardiopulmonary disease, or any other contraindication to endoscopic therapy.
③ Imaging evidence of distant metastasis or lymph-node metastasis.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jia C Sun, MM | Contact | 86-20-38379764 | sunjch8@mail.sysu.edu.cn |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 1, 2025 | Dec 24, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 1, 2025 | Dec 24, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D011127 | Polyps |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| resection margin | vertical and horizontal resection margin | Periprocedural |
| number of intra-procedural bleeding episodes | number of intra-procedural bleeding episodes | Periprocedural |
| intra-procedural blood loss | intra-procedural blood loss | Periprocedural |
| intra-procedural hemostasis time | intra-procedural hemostasis time | Periprocedural |
| other intra-procedural adverse events | perforation, infection, and other adverse eventes | Periprocedural |
| post-procedural adverse events | perforation, infection, delayed gastrointestinal bleeding, and other adverse events, | From enrollment to 30 days after the procedure. |