NCT01139424

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2010

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 8, 2010

Status Verified

May 1, 2010

Enrollment Period

2 years

First QC Date

May 28, 2010

Last Update Submit

June 7, 2010

Conditions

PostoperativeAnastomosis, Surgical

Keywords

surgical leakendoscopic suturingAnastomotic leakageesophageal or gastric resection

Outcome Measures

Primary Outcomes (2)

  • Safety

    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

    2 years

  • Technical feasibility

    Technical success of the anastomotic closure

    2 years

Secondary Outcomes (2)

  • Time to healing of the anastomotic leak

    2 years

  • Long term safety

    6 months after diagnosis of anastomotic leakage

Study Arms (1)

open label treatment arm

EXPERIMENTAL

endoscopic suturing

Device: endoscopic suturing

Interventions

endoscopic suturingDEVICE

endoscopic suturing of the anastomotic leak

Also known as: Using the Ethicon Endosurgery InScope tissue apposition system (TAS)., FDA regulation number 21 CFR 876.1500, CE#: CE0123 (G2S 09 12 57666 029)
open label treatment arm

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UKSH

Kiel, Schleswig-Holstein, 24105, Germany

Location

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Annette Fritscher-Ravens, MD

    UKSH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Annette Fritscher-Ravens, MD

CONTACT

0049-431-597-2133

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 28, 2010

First Posted

June 8, 2010

Study Start

June 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

June 8, 2010

Record last verified: 2010-05

Locations

DE(1)