Multicenter, single-blind, randomized controlled trial to evaluate the efficacy of the line-attached sheath-type traction device for endoscopic submucosal dissection in patients with superficail gastric neoplasm.

JRCT ID: jRCT1052220166

Registered date:12/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Superficial gastric neoplasm
• Date of first enrollment: 12/02/2023
• Target sample size: 142
• Study type: Interventional

Intervention(s)

Intervention group
ESD is conducted as following steps: 1) submucosal injection 2)whole circumferential mucosal incision 3)attaching a traction device 4)starting towing 5)submucosal dissection 6)en-bloc resection. Endoscopists pull ( or push) a traction device and change the length of a towing string so as to keep the traction vertical (occasionally, proximal) to the lesion .

Conventional ESD (C-ESD) group
The C-ESD procedure dose not include the traction method, underwater technique, the pocket creation method, or any other special technique. ESD procedure is dependent on endoscopic knives which endoscopists use.

Needle-type knife
1) submucosal injection 2)partial mucosal incision 3)making a mucosal flap 4)partial submucosal dissection5)whole circumferential mucosal incision 6)the completion of submucosal dissection 7)en-bloc resection

Insulation-tipped diathermic knife (IT knife)
1) submucosal injection 2)whole circumferential mucosal incision 3)submucosal dissection 4)en-bloc resection
Arrangements such as partial submucosal dissection before whole circumferential mucosal incision are permitted.

Outcome(s)

• Primary Outcome: Procedure time

Secondary Outcome

1) Efficacy-related outcomes (dissecting time, dissection speed, handover rate, en-bloc resection rate, complete en-bloc resection rate, endoscopic curability)
2) Safety-related outcomes (the number of bleeding, adverse events)
3) Device-related outcomes (attachment time, attaching points, the number of devices, the number of slip-off, damage to specimen)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Subject who are 18 years of age and more
2. Subject who understand and voluntarily sign an informed consent form.
3. Subjects who have superficial gastric neoplasm meeting the absolute or expanded indication for ESD according to the following Japanese guidelines for gastric treatment (6 edition):
i) clinically diagnosed intramucosal cancer (cT1a) representing well differentiated-type adenocarcinoma of any size, without ulcerative findings
ii) cT1a representing well-differentiated-type adenocarcinoma, less than 30 mm in size, with ulcerative findings
iii) cT1a representing undifferentiated-type adenocarcinoma, less than 20 mm in size, without ulcerative findings.
4. Subject who have computed tomography findings without any suspicious lesions of lymph node metastasis and distant metastasis.
5. Subject who have histological findings of group 4 and 5 according to group classification of gastric biopsy.
6. Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-2

Exclude criteria

1. Subjects who have lesions which is presumed to be difficult in en-bloc resection without a traction device including lesions estimated having severe fibrosis and lesions located in the esophagogastric junction, the fornix, and on the pylorus ring.
2. Subjects have a history of either gastrectomy or reconstructive surgery of the gastric tract.
3. Subjects have either regidual lesion or local reccurence after previous endoscopic treatment.
4. Subjects were registered to this trial for previous lesion.
5. Subjects who were impossible to comply with the cessation of anticoagulant or antiplatelet medications according to japanese guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment and 2017 appendix.
6. Subjects have any hemostasis / coagulation abnormality.
7. Subjects have functional failure in vital organs such as liver, kidney and heart.
8. Subjects were planned to conduct ESD for more than two gastric lesions in the same day.
9. Subjects who are pregnant, suspicious of pregnant and lactating.
10. Subjects who were deemed ineligible for a specific reason.

Related Information

• Primary Sponsor: Takao Toshitatsu