Closure of Anastomotic Leaks in the Stomach and Esophagus by Endoscopic Suturing (GASTROSUTURE)

University Hospital Schleswig-Holstein (UKSH)

Status: Unknown

Conditions: Anastomosis, Surgical; Postoperative

Treatments: Device: endoscopic suturing

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01139424

1-Fritscher-Ravens

UKSH1 (Other Identifier)

Details and patient eligibility

About

Patients with suspected leakage at the specified surgical anastomoses undergo an immediate diagnostic endoscopy as part of current clinical routine. Consenting patients meeting the inclusion criteria will undergo closure of the defect by endoscopic suturing in addition to standard surgical care.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• leakage at anastomosis within 2 weeks after upper gastrointestinal (GI) resection

Exclusion criteria

• tubular ischemia of the upper GI tract
• inability to provide informed consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

open label treatment arm

Experimental group

Description:

endoscopic suturing

Treatment:

Device: endoscopic suturing