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

Safety and Efficacy of Closure of Postoperative Anastomotic Leaks in the Stomach and Esophagus by Endoscopic Suturing: A Prospective Pilot Study

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01139424

Acronym

GASTROSUTURE

Enrollment

Registered

2010-06-08

Start date

2010-06-30

Completion date

2012-06-30

Last updated

2010-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomosis, Surgical, Postoperative

Keywords

surgical leak, endoscopic suturing, Anastomotic leakage, esophageal or gastric resection

Brief summary

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.

Interventions

DEVICEendoscopic suturing

endoscopic suturing of the anastomotic leak

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Safety	2 years	Endpoint to be recorded during hospital stay: Composite serious adverse event endpoint for 30 days after the diagnosis of anastomotic leakage including: * Death * Injury to vessels through the suture device, leading to bleeding or thrombosis * Cardiac tamponade, arrhythmia * Pneumothorax * Bleeding requiring transfusion * possible medium-term complications such as new mediastinal abscess
Technical feasibility	2 years	Technical success of the anastomotic closure

Secondary

Measure	Time frame	Description
Time to healing of the anastomotic leak	2 years	Scored during the hospital stay until 6 months after the original operation. Patients who die or undergo complete resection of the organ (e. g. esophagectomy with cervical fistula) are scored as nevel healed - i.e. censored events. Efficacy statistics need to use local historic controls and literature data. Statistical analysis will be performed using the LogRank test.
Long term safety	6 months after diagnosis of anastomotic leakage	Long term safety * Anastomotic stenosis, as assessed by endoscopy * Clinically apparent functional problems (e.g. dysphagia, incontinence)

Countries

Germany

Contacts

Primary ContactAnnette Fritscher-Ravens, MD

0049-431-597-2133

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026