An interventional study of RDI in Endoscopic Submucosal Dissection (ESD), sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-26.
Sponsored by Sixth Affiliated Hospital, Sun Yat-sen University · Not applicable, Interventional, and Treatment
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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 158 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Sixth Affiliated Hospital, Sun Yat-sen University is the lead sponsor of 217 studies on the registry; 111 are open to participants now.
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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 ( count \<50×10⁹/L or >1.5), significant cardiopulmonary disease, or any other to endoscopic therapy.
③ Imaging evidence of distant or lymph-node metastasis.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Other: RDI
The WLE group completes the entire ESD procedure using only WLE, without switching to RDI.
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).
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.
Time frame: Periprocedural
complete resection (R0) rate
complete resection (R0) rate
Time frame: Periprocedural
en-bloc resection rate
en-bloc resection rate
Time frame: Periprocedural
resection margin
vertical and horizontal resection margin
Time frame: Periprocedural
number of intra-procedural bleeding episodes
number of intra-procedural bleeding episodes
Time frame: Periprocedural
intra-procedural blood loss
intra-procedural blood loss
Time frame: Periprocedural
intra-procedural hemostasis time
intra-procedural hemostasis time
Time frame: Periprocedural
other intra-procedural adverse events
perforation, infection, and other adverse eventes
Time frame: Periprocedural
post-procedural adverse events
perforation, infection, delayed gastrointestinal bleeding, and other adverse events,
Time frame: From enrollment to 30 days after the procedure.
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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