Endoscopic Therapy for Laterally Spreading Tumors (LSTs)

NCT06464874 | Completed

• 1 other identifier: 2023-0444
• Study Type: observational
• Target: 890
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Colorectal adenoma；Laterally spreading tumors, Endoscopic submucosal dissection, Hybrid endoscopic submucosal dissection

Outcome Measures

Primary Outcomes (1)

• complete resection rate

  One-time complete excision

  2 weeks

Study Arms (2)

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.

Procedure: Conventional 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.

Procedure: Hybrid ESD

Interventions

Conventional ESD PROCEDURE

Conventional ESD is the most suitable method for total resection, especially for large lesions. This method can complete the resection of early gastrointestinal cancer and precancerous lesions, while maintaining the integrity of digestive tract anatomy and physiological function.The operation difficulty of this technique is high, the equipment requirements are high, the operation time is long, and the complication rate is closely related to the technical level of the operator.

conventional ESD

Hybrid ESD PROCEDURE

Hybrid ESD is a better choice, but only can remove the lesion in one piece, but also has a lower technical difficulty than conventional ESD

hybrid ESD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study involved a multicenter retrospective analysis of 890 consecutive patients with a colorectal LST \> 10 millimeters who underwent endoscopic treatment at 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) between May 2020 and April 2023.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, 310009, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 18, 2024
• Study Start: May 1, 2020
• Primary Completion: April 30, 2023
• Study Completion: December 30, 2023
• Last Updated: June 18, 2024

Record last verified: 2020-05

Locations

CN (1)