ACE study

JRCT ID: jRCT1032240507

Registered date:26/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Gastric adenoma or early gastric cancer that is an absolute indication for ESD.
• Date of first enrollment: 20/12/2024
• Target sample size: 64
• Study type: Interventional
• Intervention(s): Wound suturing with clips, including Mantis clips, for the high-risk group of post gastric ESD bleeding to test the effect of posterior haemorrhage control.

Outcome(s)

• Primary Outcome: Percentage of post-ESD haemorrhage

Secondary Outcome

Secondary endpoints of adverse events
1) Proportion of posterior haemorrhage (per lesion)
2) Proportion of patients with haematemesis (per patient)
3) Proportion of patients with bleeding (per patient)
4) Proportion (per patient) of patients with a decrease in Hb of 2 g/dL from the most recent blood test on the day after ESD or on suspicion of post- ESD haemorrhage.

Secondary endpoints of the procedure
1) Resection time (minutes) (from the start of specimen resection to the end of specimen resection) (per lesion)
2) Suture time (minutes) (from the start of the first clip endoscope insertion to the end of the last clip suture) (per lesion)
3) Operation time (minutes) (from the start of specimen resection to the end of the last clip suture) (per lesion)
4) Maximum diameter of the ulcer base after ESD (mm) (measured with a 10 mm disc) (per lesion)
5) Number of clips used (excluding clips that fell out) (per lesion)
6) Percentage of complete sutures (number of lesions with complete sutures/number of successfully sutured lesions) (per lesion)
7) Incomplete suture rate (number of lesions with incomplete suture/number of successfully sutured lesions) (per lesion)
8) Suture success rate (number of successfully sutured lesions/total number of lesions) (per lesion)
9) Percentage of dead space (pocket) formation (determined when the surgeon completes the clip suture; a dead space is defined as an obvious submucosal space) (per lesion).

Secondary efficacy endpoints
1) Short-term clip survival rate (calculated as the number of remaining clips/clips at the time of suture (%) that can be determined by the reviewer after performing a simple abdominal X-ray examination on Day 21 with Day 0 as the date of ESD, but not calculated in cases where the examination was unavoidable) (per lesion).
2) Long-term clip survival rate (calculated as the number of clips/clips at suture that remain after upper gastrointestinal endoscopy on Day 84 with Day 0 as the date after ESD, as judged by the reviewer, but not calculated in cases where examination could not be performed due to unavoidable circumstances) (per lesion)

Secondary safety endpoints
The complication rate as a safety endpoint (intraoperative perforation caused by clips (intraoperative perforation is in principle a cause for discontinuation, but only this item is included in the analysis), delayed perforation, PECS, and adverse events are evaluated using the NCI-Common Terminology Criteria for Adverse Events v5.0 Japanese translation (JCOG). Criteria for Adverse Events v5.0 (CTCAE v5.0) Japanese translation).

Intraoperative perforation: obvious perforation endoscopically observed intraoperatively
Delayed perforation: abdominal pain with free air on post-operative CT despite no intraoperative perforation.
PECS (post-ESD coagulopathy): localised abdominal pain with inflammation (e.g. elevated CRP) without obvious perforation.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who meet all of the following criteria are eligible.
1) Gastric adenoma or early gastric cancer that is considered an indication for ESD.
(For early gastric cancer, patients judged preoperatively to be absolutely eligible for ESD according to the Society of Gastrointestinal Endoscopy's ESD/EMR Guidelines for Gastric Cancer (2nd edition)).
2) Cases with no obvious metastases (other organ and lymph node metastases) confirmed by preoperative CT.
3) Patients who have not undergone upper and lower gastrointestinal endoscopic treatment within 28 days.
4) Patients aged 20 years or over at the time of consent (regardless of gender).
5) Patients who have been fully informed about the study and who have given their free written consent based on a thorough understanding of the study
6) Patients whose lesion diameter is endoscopically considered to be less than 50 mm.
7) Patients with a BEST-J score of 2 or more points (patients with an intermediate risk or higher of posterior bleeding in the BEST-J score).

Exclude criteria

Persons who meet any of the following conditions are not eligible.
1) Pregnant patients.
2) American Society of Anaesthesiologists Classification IV or higher (serious life-threatening systemic illness at any time).
3) Patients who cannot respond to antithrombotic drugs according to guidelines.
4) Lesions considered difficult to suture after ESD.
5) Other patients deemed unsuitable for the safe conduct of the study by the study investigators or sub-investigators.

Related Information

• Primary Sponsor: Okimoto Kenichiro
• Source(s) of Monetary Support: Chiba University Hospital