Early Gastric Cancer or Gastric AdenomaNCT07401303
Full-time RDI for ESD: Impact on Major Adverse Events and Procedure Time
A study testing ESD in people with Early Gastric Cancer or Gastric Adenoma, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
Gastric cancer remains a major global health burden, ranking fifth in incidence worldwide and disproportionately affecting Asia, with China accounting for a significant share of cases and deaths. Early detection and minimally invasive treatment are critical to improving outcomes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Early Gastric Cancer or Gastric Adenoma
- What is being tested?
- ESD
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- scheduled to undergo ESD for an early gastric cancer (the indication for ESD under current guidelines)
- both genders aged 18-75 years
- no pretreatment (ESD, surgery, radiation therapy, or chemotherapy) performed on the stomach to be examined
- platelet count of >10×10^9/L and hemoglobin count of >8.0 g/L in blood tests performed in the 3 months before the ESD
- "antithrombotic drugs" have been withdrawn for the period recommended by current guidelines
- written consent provided at the patient's discretion
Who cannot join
- scheduled for hybrid ESD
- scheduled for ESD due to multiple lesions
- scheduled for treatment of lesions with residual recurrence
- presence of submucosal tumors
- unable to discontinue an antithrombotic drugs at the time of informed consent
- inherited or acquired coagulopathy likely to affect the risk of bleeding
Show all 9Show fewer
- receiving maintenance dialysis
- deemed unsuitable for participation in this study by the principal investigator or other investigators
- unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, 710032
Zhiguo Liu, MD, PhD, 84771535, liuzhiguo@fmmu.edu.cn
About this study
Official title: The Effect of Full-time RDI on the Incidence of Major Adverse Intraoperative or Delayed Events and the Proportion of ESD Procedures With Prolonged Procedure Time: A Multicenter Prospective Randomized Controlled Trial
Gastric cancer remains a major global health burden, ranking fifth in incidence worldwide and disproportionately affecting Asia, with China accounting for a significant share of cases and deaths. Early detection and minimally invasive treatment are critical to improving outcomes. Endoscopic submucosal dissection (ESD) is the preferred curative approach for early gastric cancer, enabling precise, en bloc tumor resection while preserving gastric function. However, ESD is technically complex, time-consuming, and associated with risks such as intraoperative and delayed bleeding and perforation. These complications limit its widespread adoption, particularly outside East Asia.
Traditional ESD relies on white light imaging (WLI), which offers limited visualization of submucosal vessels and bleeding sources. Red Dichromatic Imaging (RDI) is an emerging image-enhanced endoscopy technology that uses specific narrow-band wavelengths to enhance the contrast of deep blood vessels and active bleeding sites by exploiting hemoglobin's optical absorption characteristics. Preliminary studies indicate that RDI improves bleeding point identification, facilitates hemostasis, and reduces endoscopists' procedural stress. However, prior research applied RDI only intermittently during bleeding events, leaving its potential benefits throughout the entire ESD procedure unexplored.
Read more
The "full-time RDI" concept proposes continuous use of RDI during all ESD stages-including submucosal injection, mucosal incision, dissection, and wound management-to enhance visualization of high-risk vessels, improve layer differentiation, and potentially reduce adverse events and operation time. Despite promising retrospective data, robust prospective evidence from large randomized controlled trials is lacking.
This multicenter, prospective randomized controlled trial aims to evaluate whether full-course RDI reduces major intraoperative and delayed complications and decreases unexpectedly prolonged operation times compared to conventional WLI-guided ESD in early gastric cancer. Secondary endpoints include procedural efficiency, safety across lesion locations, and operator stress.
By rigorously assessing full-time RDI's clinical value, this study addresses an urgent unmet need to improve ESD safety and efficiency, potentially broadening its application and enhancing patient outcomes. The innovation lies in integrating continuous advanced imaging throughout ESD, representing a significant advancement in endoscopic oncology and minimally invasive gastric cancer treatment.
- Conditions
- Early Gastric Cancer or Gastric Adenoma
- Being tested
- ESD
- Keywords
- endoscopic submucosal dissection, ESD, red dichromatic imaging, RDI, bleeding, perforation
- Medical subject headings
- Stomach Neoplasms, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESDProcedure or surgery
Also called Endoscopic Submucosal Dissection
Endoscopic Submucosal Dissection (ESD) is a minimally invasive endoscopic technique used to remove early-stage gastrointestinal tumors and precancerous lesions en bloc. Developed initially for the treatment of early gastric cancer, ESD allows for precise dissection of the submucosal layer beneath the lesion, enabling complete resection with clear margins while preserving the integrity of the surrounding tissue. This technique offers advantages over traditional endoscopic mucosal resection (EMR) by enabling the removal of larger and more complex lesions, reducing recurrence rates, and minimizing the need for invasive surgery.
| Study group | Role | What they receive |
|---|---|---|
| Full-time RDI | Experimental | Full-time Red Dichromatic Imaging (RDI) refers to the continuous application of RDI technology throughout the entire endoscopic submucosal dissection (ESD) procedure. This approach encompasses all procedural phases, including submucosal injection, circumferential mucosal incision, submucosal dissection, and post-resection wound management, with the aim of enhancing visualization of submucosal vessels and bleeding sources in real time to improve hemostasis, reduce complications, and increase procedural efficiency. Receives: Procedure: ESD |
| Full-time WLI | Active comparator | Full-time White Light Imaging (WLI) refers to the continuous use of standard white light endoscopic imaging throughout the entire endoscopic submucosal dissection (ESD) procedure. This conventional approach involves relying solely on white light visualization during all stages of the procedure-including submucosal injection, mucosal incision, submucosal dissection, and post-resection wound assessment-without the aid of enhanced imaging modalities for vessel or bleeding source identification. Receives: Procedure: ESD |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of major intraoperative or delayed adverse events and/or ESD procedures with operation time exceeding the expected duration
Major adverse events include use of hemostatic forceps for bleeding control, significant delayed bleeding, and perforation during or after ESD. Hemostatic forceps are used if bleeding persists after three electrocautery attempts or if the operator deems electrocautery insufficient. Delayed bleeding occurs mostly within 48 hours, marked by clinical signs needing hemostasis or transfusion, or >20 g/L hemoglobin drop. Perforation is diagnosed by visible gastric wall defects or post-ESD peritoneal irritation with free gas on imaging. Expected ESD time (min) = 2.384 × tumor size (mm) + 38.568 × location (1=upper third, 0=others) + 40.333 × ulcer presence (1=yes, 0=no). Procedures exceeding 110% of this time are analyzed by lesion and specimen size.
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (12)
Incidence of major intraoperative or delayed adverse events
Major adverse events include use of hemostatic forceps for bleeding control, significant delayed bleeding, and perforation during or after ESD. Hemostatic forceps are applied before lesion removal and used until bleeding is fully controlled if: (1) bleeding persists after three electrocautery attempts; (2) the operator judges electrocautery insufficient; or (3) exposed vessels cannot be controlled by electrocautery. Use is allowed if either condition (2) or (3) applies, even without (1). Delayed bleeding usually occurs within 48 hours but can last up to 2 weeks, defined by clinical signs (hypotension, tachycardia, hematemesis, melena, hematochezia) requiring endoscopic hemostasis or transfusion, or hemoglobin drop >20 g/L. Intraoperative perforation is a visible gastric wall defect with exposed fat or peritoneal cavity; delayed perforation shows peritoneal irritation and free gas on postoperative imaging.
Measured: From enrollment to the end of treatment at 4 weeks
Incidence of ESD procedures exceeding 110% of the expected procedure time
Expected operation time = 2.384 × tumor size (mm) + 38.568 × location + 40.333 × ulcer presence; where location is assigned 1 for tumors in the upper third of the stomach and 0 for tumors in the middle or lower third; ulcer presence is assigned 1 if ulcers are present and 0 if absent.
An ESD procedure is considered to exceed 110% of the expected operation time if its actual duration surpasses the estimated time by more than 10%. Analyses can be performed separately based on the preoperative estimated lesion size and the size of the resected specimen.
Measured: Throughout the ESD procedure
Number of ESD procedures requiring hemostatic forceps for hemostasis
The outcome measure reports the number of ESD procedures requiring hemostatic forceps for bleeding control. Procedures were counted as requiring hemostatic forceps if forceps were applied to achieve hemostasis during the procedure. The count ranges from zero (no procedures requiring forceps) to the total number of ESD procedures performed.
Measured: Throughout the ESD procedure
Number of hemostatic forceps uses during ESD
The outcome measure reports the number of times hemostatic forceps were used during ESD. The count ranges from zero, indicating no use of hemostatic forceps, to the maximum number of uses recorded during the procedure. A higher count reflects more frequent use of hemostatic forceps for bleeding control during ESD.
Measured: Throughout the ESD procedure
Number of hemostatic interventions during the procedure (regardless of type)
The outcome measure reports the number of hemostatic interventions performed during the procedure, regardless of the intervention type. The count ranges from zero, indicating no hemostatic intervention was required, to the maximum number of interventions recorded in a procedure. A higher count indicates more frequent hemostatic interventions to control bleeding during the procedure.
Measured: Throughout the ESD procedure
Number of spurting hemorrhages (Forrest classification Ia)
The outcome measure reports the number of spurting hemorrhages classified as Forrest Ia observed during the procedure. The count ranges from zero, indicating no spurting hemorrhages, to the maximum number identified. A higher number reflects a greater severity of active arterial bleeding according to the Forrest classification.
Measured: Throughout the ESD procedure
Procedure time (minutes) and submucosal dissection time (minutes)
Procedure time (minutes) is defined as the time from the start of mucosal incision to the complete removal of the lesion. Submucosal dissection time (minutes) is defined as the time from the completion of circumferential mucosal incision to the end of complete lesion removal. The outcome measures report time durations in minutes.
Measured: Throughout the ESD procedure
Dissection speed (mm²/min)
The outcome measure reports dissection speed in mm²/min, which is calculated by dividing the specimen area (mm²) by the submucosal dissection time (minutes). Specimen area is determined using the elliptical formula: area (mm²) = longest diameter (mm) × shortest diameter (mm) × 0.25 × 3.14. Dissection speed ranges from zero (no tissue dissected per minute) to the maximum speed recorded. Higher values indicate faster dissection during the procedure.
Measured: Throughout the ESD procedure
Volume of submucosal injection solution used
The outcome measure reports the volume of submucosal injection solution used, calculated as the initial prepared volume minus the remaining volume (measured in milliliters, ml). The volume ranges from zero, indicating no solution was used, to the maximum amount prepared. Greater volumes reflect higher usage of injection solution during the procedure.
Measured: Throughout the ESD procedure
Rates of en bloc resection
En bloc resection is defined as the complete removal of the target lesion in a single piece without piecemeal resection. Participants are considered to have achieved this outcome if their lesions meet these criteria. Rates range from 0% (no participants achieving the outcome) to 100% (all participants achieving the outcome), with higher rates indicating better procedural success.
Measured: From enrollment to the end of treatment at 4 weeks
Rates of complete resection
Complete resection is confirmed by histological examination showing negative horizontal and vertical margins. Participants are considered to have achieved this outcome if their lesions meet these criteria. Rates range from 0% (no participants achieving the outcome) to 100% (all participants achieving the outcome), with higher rates indicating better procedural success.
Measured: From enrollment to the end of treatment at 4 weeks
Rates of curative resection
Curative resection is determined according to the Japanese Gastric Cancer Guidelines, classified as endoscopic cure categories A, C-1, and C-2.
Participants are considered to have achieved this outcome if their lesions meet these criteria. Rates range from 0% (no participants achieving the outcome) to 100% (all participants achieving the outcome), with higher rates indicating better procedural success.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start1 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Gastric Cancer or Gastric AdenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiguo Liu, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401303
- Sponsor's protocol ID
- XJ-ESD-RDI
- Status last verified
- Aug 2026
- First submitted
- 3 Feb 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Full-time RDI on the Incidence of Major Adverse Intraoperative or Delayed Events and the Proportion of ESD Procedures With Prolonged Procedure Time: A Multicenter Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07401303
- Acronym / sponsor ID
- XJ-ESD-RDI
- Conditions
- Early Gastric Cancer or Gastric Adenoma
- Keywords
- endoscopic submucosal dissection, ESD, red dichromatic imaging, RDI, bleeding, perforation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gastric cancer remains a major global health burden, ranking fifth in incidence worldwide and disproportionately affecting Asia, with China accounting for a significant share of cases and deaths. Early detection and minimally invasive treatment are critical to improving outcomes. Endoscopic submucosal dissection (ESD) is the preferred curative approach for early gastric cancer, enabling precise, en bloc tumor resection while preserving gastric function. However, ESD is technically complex, time-consuming, and associated with risks such as intraoperative and delayed bleeding and perforation. These complications limit its widespread adoption, particularly outside East Asia.
Traditional ESD relies on white light imaging (WLI), which offers limited visualization of submucosal vessels and bleeding sources. Red Dichromatic Imaging (RDI) is an emerging image-enhanced endoscopy technology that uses specific narrow-band wavelengths to enhance the contrast of deep blood vessels and active bleeding sites by exploiting hemoglobin's optical absorption characteristics. Preliminary studies indicate that RDI improves bleeding point identification, facilitates hemostasis, and reduces endoscopists' procedural stress. However, prior research applied RDI only intermittently during bleeding events, leaving its potential benefits throughout the entire ESD procedure unexplored.
The "full-time RDI" concept proposes continuous use of RDI during all ESD stages-including submucosal injection, mucosal incision, dissection, and wound management-to enhance visualization of high-risk vessels, improve layer differentiation, and potentially reduce adverse events and operation time. Despite promising retrospective data, robust prospective evidence from large randomized controlled trials is lacking.
This multicenter, prospective randomized controlled trial aims to evaluate whether full-course RDI reduces major intraoperative and delayed complications and decreases unexpectedly prolonged operation times compared to conventional WLI-guided ESD in early gastric cancer. Secondary endpoints include procedural efficiency, safety across lesion locations, and operator stress.
By rigorously assessing full-time RDI's clinical value, this study addresses an urgent unmet need to improve ESD safety and efficiency, potentially broadening its application and enhancing patient outcomes. The innovation lies in integrating continuous advanced imaging throughout ESD, representing a significant advancement in endoscopic oncology and minimally invasive gastric cancer treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full-time RDI | Experimental | Procedure: ESDFull-time Red Dichromatic Imaging (RDI) refers to the continuous application of RDI technology throughout the entire endoscopic submucosal dissection (ESD) procedure. This approach encompasses all procedural phases, including submucosal injection, circumferential mucosal incision, submucosal dissection, and post-resection wound management, with the aim of enhancing visualization of submucosal vessels and bleeding sources in real time to improve hemostasis, reduce complications, and increase procedural efficiency. |
| Full-time WLI | Active comparator | Procedure: ESDFull-time White Light Imaging (WLI) refers to the continuous use of standard white light endoscopic imaging throughout the entire endoscopic submucosal dissection (ESD) procedure. This conventional approach involves relying solely on white light visualization during all stages of the procedure-including submucosal injection, mucosal incision, submucosal dissection, and post-resection wound assessment-without the aid of enhanced imaging modalities for vessel or bleeding source identification. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- scheduled to undergo ESD for an early gastric cancer (the indication for ESD under current guidelines)
- both genders aged 18-75 years
- no pretreatment (ESD, surgery, radiation therapy, or chemotherapy) performed on the stomach to be examined
- platelet count of >10×10^9/L and hemoglobin count of >8.0 g/L in blood tests performed in the 3 months before the ESD
- "antithrombotic drugs" have been withdrawn for the period recommended by current guidelines
Key exclusion criteria (9 listed)
- scheduled for hybrid ESD
- scheduled for ESD due to multiple lesions
- scheduled for treatment of lesions with residual recurrence
- presence of submucosal tumors
- unable to discontinue an antithrombotic drugs at the time of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESDAlso: Endoscopic Submucosal DissectionEndoscopic Submucosal Dissection (ESD) is a minimally invasive endoscopic technique used to remove early-stage gastrointestinal tumors and precancerous lesions en bloc. Developed initially for the treatment of early gastric cancer, ESD allows for precise dissection of the submucosal layer beneath the lesion, enabling complete resection with clear margins while preserving the integrity of the surrounding tissue. This technique offers advantages over traditional endoscopic mucosal resection (EMR) by enabling the removal of larger and more complex lesions, reducing recurrence rates, and minimizing the need for invasive surgery. | Procedure or surgery | Full-time RDI, Full-time WLI |
Primary outcome
the incidence of major intraoperative or delayed adverse events and/or ESD procedures with operation time exceeding the expected duration
Time frame: From enrollment to the end of treatment at 4 weeks
Major adverse events include use of hemostatic forceps for bleeding control, significant delayed bleeding, and perforation during or after ESD. Hemostatic forceps are used if bleeding persists after three electrocautery attempts or if the operator deems electrocautery insufficient. Delayed bleeding occurs mostly within 48 hours, marked by clinical signs needing hemostasis or transfusion, or >20 g/L hemoglobin drop. Perforation is diagnosed by visible gastric wall defects or post-ESD peritoneal irritation with free gas on imaging. Expected ESD time (min) = 2.384 × tumor size (mm) + 38.568 × location (1=upper third, 0=others) + 40.333 × ulcer presence (1=yes, 0=no). Procedures exceeding 110% of this time are analyzed by lesion and specimen size.
12 secondary outcomes
Incidence of major intraoperative or delayed adverse events
Time frame: From enrollment to the end of treatment at 4 weeks
Incidence of ESD procedures exceeding 110% of the expected procedure time
Time frame: Throughout the ESD procedure
Number of ESD procedures requiring hemostatic forceps for hemostasis
Time frame: Throughout the ESD procedure
Number of hemostatic forceps uses during ESD
Time frame: Throughout the ESD procedure
Number of hemostatic interventions during the procedure (regardless of type)
Time frame: Throughout the ESD procedure
Number of spurting hemorrhages (Forrest classification Ia)
Time frame: Throughout the ESD procedure
Procedure time (minutes) and submucosal dissection time (minutes)
Time frame: Throughout the ESD procedure
Dissection speed (mm²/min)
Time frame: Throughout the ESD procedure
Volume of submucosal injection solution used
Time frame: Throughout the ESD procedure
Rates of en bloc resection
Time frame: From enrollment to the end of treatment at 4 weeks
Rates of complete resection
Time frame: From enrollment to the end of treatment at 4 weeks
Rates of curative resection
Time frame: From enrollment to the end of treatment at 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESD in people with Early Gastric Cancer or Gastric Adenoma, run by Xijing Hospital of Digestive Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui Chen, MD, PhD (02984771535, qychenhui@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of major intraoperative or delayed adverse events and/or ESD procedures with operation time exceeding the expected duration (time frame: From enrollment to the end of treatment at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.