Endoscopic Therapy for Laterally Spreading Tumors (LSTs)

Completed

• Conditions: To Compare the Efficacy and Safety of Hybrid ESD and ESD in the Treatment of Colorectal LST
• Interventions: Procedure: Conventional ESD; Procedure: Hybrid ESD

• Registration Number: NCT06464874
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-05
• Study Start: 2020-05-01
• Primary Completion: 2023-04-30
• Study Completion: 2023-12-30
• Study First Submitted: 2024-06-13
• Study First Submitted QC: 2024-06-13
• Last Update Submitted: 2024-06-13
• Study First Posted: 2024-06-18
• Last Update Posted: 2024-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 890

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
conventional ESD	Conventional ESD	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.
hybrid ESD	Hybrid ESD	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.

Primary Outcome Measures

Name	Time	Method
complete resection rate	2 weeks	One-time complete excision

Trial Locations

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China; 🇨🇳 Hangzhou, Zhejiang, China