EDLS-clips in Endoscopic Full-thickness Resection

NCT07305038 | Completed

• 1 other identifier: End-D-F1
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

A retrospective analysis was conducted on patients who visited from March 2022 to May 2024 and underwent endoscopic full-thickness resection and double-layer suture with titanium clips under endoscopy. The basic clinical information, tumor characteristics, overall resection rate and postoperative complications of all patients were evaluated. To analyze the clinical effect of double-layer suture technique with titanium clips under endoscopy in clamping the wound surface after full-thickness endoscopic resection.

Conditions

Gastric Submucosal Tumors; Endoscopic Full Thickness Resection (EFTR)

Keywords

endoscopic submucosal dissection; endoscopic full-thickness resection; endoscopic double-layer suturing method with metallic clips; submucosal tumors

Outcome Measures

Primary Outcomes (1)

• The complete closure rate of EDLS-clips

  Successful closure refers to the full coverage of the mucosal defect by surrounding normal mucosa without any gaps.

  Perioperative/Periprocedural

Secondary Outcomes (2)

• Operative time

  Perioperative/Periprocedural

• Suturing time

  Perioperative/Periprocedural

Interventions

endoscopic double-layer suturing method with metallic clips PROCEDURE

This study comprises case series of 43 patients with gastric SMTs who underwent EDLS-clips after EFTR in our center.

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 comprises case series of 43 patients with gastric SMTs who underwent EDLS-clips after EFTR in our center from March 2022 to May 2024.

You may qualify if:

• Having a tumor located in the stomach and confirmed to originate from the muscularis propria on endoscopic ultrasonography (EUS);
• Having a tumor diameter \>1 cm, which can be completely resected using endoscopic techniques, and with low risk of residue and recurrence;
• Preoperative assessment excluded those with lymph node or distant metastasis;
• Being able to tolerate tracheal intubation anesthesia, with no coagulation dysfunction or anticoagulant drugs stopped before EFTR.

You may not qualify if:

• Patients who have been evaluated preoperatively and are considered to have lymph node or distant metastasis;
• who cannot tolerate general anesthesia with endotracheal intubation,
• who have not discontinued anticoagulant drugs before EFTR or have coagulation dysfunction.

Sponsors & Collaborators

• First Hospital of China Medical University: lead

Study Sites (1)

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: December 26, 2025
• Study Start: March 1, 2022
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)