NCT05190042

Brief Summary

The use of clips to completely clip mucosal defects after ESD/EMR can reduce postoperative adverse events, but the rate of incomplete mucosal defects closure is high. The continuous suture technique can completely close the mucosal defects by using surgical sutures and clips to suture the mucosal defects after ESD/EMR. In this study, a clinical randomized controlled study was conducted in our hospital. A total of 62 enrolled patients were divided into two groups, 31 patients were set as a treatment group using continuous suture technique to close post-EMR/ESD mucosal/submucosal defects, the rest patients were set as a control group using clips. The safety and effectiveness of continuous sutures and clips to clamp the post-EMR/ESD mucosal/submucosal defect were compared in the two groups. The complete mucosal/submucosa defects closure rates were the primary outcome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 13, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

January 18, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

November 23, 2021

Last Update Submit

March 30, 2024

Conditions

Colonic PolypGastrointestinal Neoplasms

Keywords

Endoscopic mucosal resectionEndoscopic submucosal dissectionGastrolintestinal polypsContinuous sutureClips

Outcome Measures

Primary Outcomes (1)

  • The rates of complete closure of mucosal/submucosal defects

    When the clips were applied next to each other and there were no substantial submucosal areas in the closure line

    1day

Secondary Outcomes (6)

  • The duration time of closure

    1 day

  • The closure speed

    1day

  • Immediate bleeding

    1 day

  • Delayed bleeding

    14 days

  • Delayed perforation

    14 days

  • +1 more secondary outcomes

Study Arms (2)

Continuous suture group

EXPERIMENTAL

Surgical sutures were used to completely close the post-EMR/ESD mucosal/submucosal defects. This group was set as a experimental group.

Device: Cotinuous suture

Clips group

ACTIVE COMPARATOR

Clips were used to completely close the post-EMR/ESD mucosal/submucosal defects. This group was set as a control group.

Device: Clips

Interventions

Cotinuous sutureDEVICE

Cotinuous suture using surgery thread

Continuous suture group
ClipsDEVICE

Hemostatic clips

Clips group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The indications for endoscopic resection were large (≥20mm in diameter), nonpedunculated, benign, and early malignant mucosal or submucosal gastric or colorectal lesions.
  • Written informed consent

You may not qualify if:

  • The tumor has spread to the muscularis layer, lymph nodes, or distal metastases;
  • Multiple lesions (≥20mm in diameter) ;
  • Underlying bleeding disorder;
  • The platelet count less than 50×10\^9/L;
  • Serious cardio-pulmonary, hepatic or renal disease;
  • Intolerance to endoscopy;
  • Other high-risk conditions or disease (such as massive ascites, etc.);
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fifth Medical Center of Chinese PLA General Hosptial

Beijing, Beijing Municipality, 100039, China

Location

MeSH Terms

Conditions

Colonic PolypsGastrointestinal Neoplasms

Interventions

Surgical Instruments

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and Supplies

Study Officials

  • Yan Liu, MD

    Beijing 302 Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This was a single-blind study where patients were not informed about their randomization allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2021

First Posted

January 13, 2022

Study Start

January 18, 2022

Primary Completion

June 30, 2022

Study Completion

July 30, 2022

Last Updated

April 2, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)