Endoscopic Submucosal Dissection (ESD)
Conditions
Keywords
ESD, RDI, early cancer, polyp
Brief summary
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.
Interventions
OTHERRDI
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).
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangdong Second Provincial General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. * Lesion diameter 20-60 mm. ⑤ Written informed consent provided voluntarily.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mean resection speed (mm²/min) achieved with RDI versus conventional WLE during ESD | Periprocedural | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| en-bloc resection rate | Periprocedural | en-bloc resection rate |
| resection margin | Periprocedural | vertical and horizontal resection margin |
| number of intra-procedural bleeding episodes | Periprocedural | number of intra-procedural bleeding episodes |
| intra-procedural blood loss | Periprocedural | intra-procedural blood loss |
| intra-procedural hemostasis time | Periprocedural | intra-procedural hemostasis time |
| other intra-procedural adverse events | Periprocedural | perforation, infection, and other adverse eventes |
| complete resection (R0) rate | Periprocedural | complete resection (R0) rate |
| post-procedural adverse events | From enrollment to 30 days after the procedure. | perforation, infection, delayed gastrointestinal bleeding, and other adverse events, |
Contacts
CONTACTJia C Sun, MM
Outcome results
None listed