Effectiveness of endoscopic suturing method by each defect diamter for LECS of less than 3cm GIMT

JRCT ID: jRCT1062210091

Registered date:29/03/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Gastrointestinal mesenchymal tumor
• Date of first enrollment: 11/03/2022
• Target sample size: 10
• Study type: Interventional
• Intervention(s): In addition to conventional LECS,endoscopic full thickness suture is added from the gastrointestinal lumen side.We performed full thickness suture with using OTSC(with E-LOC) or using loop snare closure.

Outcome(s)

• Primary Outcome: The success rate of endoscopic full thickness suture.

Secondary Outcome

(1)The success rate of endoscopic full thickness suture by each suturing method.
(2) Endoscopic sutring time.
(3)Diameter of the lesion and defect.
(4)Additional laparoscopic suturing time.
(5)Total procedure time.
(6) The rate of complication associated with this clinical study.
(7)Possibility of inverting full thickness by each suturing method.
(8)The status of suturing site with endoscopic examination POD7.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients who will taking LECS for GIMT of intraductal growth or intramural growth in diameter less than 3cm

Exclude criteria

1)Patients who may be difficult to evaluate under laparoscope
2)Patients who have other disease and want short time with surgery
3)Patients who with psychosis or psychiatric sumptoms, and are judged to have difficulty in conduction this clinical study.

Related Information

• Primary Sponsor: Nishiyama Noriko