Endoscopic Therapy for Laterally Spreading Tumors (LSTs)

Zhejiang University

Status: Completed

Conditions: To Compare the Efficacy and Safety of Hybrid ESD and ESD in the Treatment of Colorectal LST

Treatments: Procedure: Conventional ESD; Procedure: Hybrid ESD

Study type: Observational

Funder types: Other

Identifiers

NCT06464874

2023-0444

Details and patient eligibility

About

This study will retrospectively include LST patients who were admitted to 6 medical centers (The Second Affiliated Hospital, College of Medicine, Zhejiang University; The Affiliated Jinhua Hospital, Zhejiang University School of Medicine; First Affiliated Hospital of Huzhou University; The Second Hospital of Jiaxing; Jinhua People's Hospital; Lanxi People's Hospital) from 2020.05.01 to 2023.04.30 with the purpose of comparing the efficacy and safety of hybrid ESD and ESD in the treatment of colorectal LST. The complete resection rate, operation time, operation cost, intraoperative and postoperative complications of hybrid ESD and ESD LST will be compared. To provide strong evidence for the selection of endoscopic treatment strategies for LST.

Enrollment: 890 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years old;
• LST lesion diameter >1cm;
• Medical record data integrity

Exclusion criteria

• Pedicle lesions;
• Resection of residual lesions after endoscopic treatment;
• Advanced endoscopic imaging showed submucosal infiltrating lesions.
• The lesions are in patients with inflammatory bowel disease;
• Familial polyposis;
• Electrolyte abnormalities;
• Coagulation dysfunction;
• Pregnant or lactating patients;
• Taking nonsteroidal anti-inflammatory drugs or anticoagulants;
• A history of alcoholism;
• Severe organ failure;
• Medical records are incomplete

Trial design

890 participants in 2 patient groups

conventional ESD

Description:

Submucosal injection of methylene blue solution at various sites was performed, followed by periphery incision using a dual knife. The submucosal injection was administered multiple times, followed by the utilization of an IT knife for submucosal separation and gradual excision of the lesion. In cases of significant bleeding at the wound site, electrocoagulation hemostatic forceps were employed for hemostasis.

Treatment:

Procedure: Conventional ESD

hybrid ESD

Description:

The submucosal injection and circumferential incision of the Hybrid ESD were performed as described above. Subsequently, snaring was conducted post submucosal dissection utilizing a polypectomy snare for complete lesion removal. Careful attention was paid during excision to avoid muscle layer penetration and to control cutting speed in order to mitigate the potential for hemorrhage and perforation. The subsequent steps of the procedure closely followed the conventional ESD methodology outlined previously.

Treatment:

Procedure: Hybrid ESD