Prospective evaluation of the effect of anchor pronged clip closure on delayed bleeding in high risk patientsafter gastric endoscopic submucosal dissection. (ACE study)

未提供0 个研究点目标入组 64 人开始时间: 2024年12月20日最近更新: 2025年3月24日

试验速览

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•Patients who meet all of the following criteria are eligible.
•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)).
•Cases with no obvious metastases (other organ and lymph node metastases) confirmed by preoperative CT.
•Patients who have not undergone upper and lower gastrointestinal endoscopic treatment within 28 days.
•Patients aged 20 years or over at the time of consent (regardless of gender).
•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
•Patients whose lesion diameter is endoscopically considered to be less than 50 mm.
•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).

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

Percentage of post-ESD haemorrhage

Proportion of posterior haemorrhage
Proportion of patients with haematemesis
Proportion of patients with bleeding
Proportion of patients with a decrease in Hb of 2 g/dL(day after ESD or on suspicion of post-ESD haemorrhage)
Resection time
Suture time
Operation time
Maximum diameter of the ulcer base after ESD
Number of clips used
Percentage of complete sutures
Incomplete suture rate
Suture success rate
Percentage of dead space (pocket) formation
Short-term clip survival rate(Day 21)
Long-term clip survival rate(Day 84)
Complication rate
Intraoperative perforation
Delayed perforation
PECS (post-ESD coagulopathy)

发起方

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