Full-time RDI for ESD: Impact on Major Adverse Events and Procedure Time

N/ANot Yet RecruitingNCT07401303

Xijing Hospital of Digestive Diseases640 enrolled

Overview

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 Type

INTERVENTIONAL

Interventions

ESDPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * receiving maintenance dialysis * deemed unsuitable for participation in this study by the principal investigator or other investigators * unable to provide informed consent

Outcomes

Primary Outcomes

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.

Time frame: From enrollment to the end of treatment at 4 weeks

Secondary Outcomes

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.

Time frame: 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.