PostoperativeGASTROSUTURENCT01139424
Closure of Anastomotic Leaks in the Stomach and Esophagus by Endoscopic Suturing
A study testing endoscopic suturing in people with Postoperative and Anastomosis, Surgical, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Postoperative, Anastomosis, Surgical
- What is being tested?
- endoscopic suturing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2010to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- leakage at anastomosis within 2 weeks after upper gastrointestinal (GI) resection
Who cannot join
- tubular ischemia of the upper GI tract
- inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Annette Fritscher-Ravens, MD contact
Germany1 site
UKSH
Kiel, Schleswig-Holstein, 24105
Annette Fritscher-Ravens, MD, 0049-431-597-2133, fritscher-ravens@1med.uni-kiel.de
Gudrun Gebhard, 0049-431-597-1464, Gudrun.Gebhardt@uk-sh.de
About this study
Official title: Safety and Efficacy of Closure of Postoperative Anastomotic Leaks in the Stomach and Esophagus by Endoscopic Suturing: A Prospective Pilot Study
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.
- Conditions
- Postoperative, Anastomosis, Surgical
- Being tested
- endoscopic suturing
- Keywords
- surgical leak, endoscopic suturing, Anastomotic leakage, esophageal or gastric resection
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic suturingDevice
Also called Using the Ethicon Endosurgery InScope tissue apposition system (TAS)., FDA regulation number 21 CFR 876.1500, CE#: CE0123 (G2S 09 12 57666 029)
endoscopic suturing of the anastomotic leak
| Study group | Role | What they receive |
|---|---|---|
| open label treatment arm | Experimental | endoscopic suturing Receives: Device: endoscopic suturing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Technical feasibility
Technical success of the anastomotic closure
Measured: 2 years
Secondary outcomes (2)
Time to healing of the anastomotic leak
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.
Measured: 2 years
Long term safety
Long term safety
- Anastomotic stenosis, as assessed by endoscopy
- Clinically apparent functional problems (e.g. dysphagia, incontinence)
Measured: 6 months after diagnosis of anastomotic leakage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon Endo-Surgery
- Investigators
- Annette Fritscher-Ravens, MD, Principal investigator, UKSH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01139424
- Sponsor's protocol ID
- 1-Fritscher-Ravens
- Other IDs
- UKSH1
- Acronym
- GASTROSUTURE
- Status last verified
- May 2010
- First submitted
- 28 May 2010
- Last updated
- 8 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Closure of Postoperative Anastomotic Leaks in the Stomach and Esophagus by Endoscopic Suturing: A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT01139424
- Acronym / sponsor ID
- GASTROSUTURE / 1-Fritscher-Ravens
- Conditions
- Postoperative, Anastomosis, Surgical
- Keywords
- surgical leak, endoscopic suturing, Anastomotic leakage, esophageal or gastric resection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Collaborators
- Ethicon Endo-Surgery
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 8 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open label treatment arm | Experimental | Device: endoscopic suturingendoscopic suturing |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- leakage at anastomosis within 2 weeks after upper gastrointestinal (GI) resection
Key exclusion criteria (2 listed)
- tubular ischemia of the upper GI tract
- inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopic suturingAlso: Using the Ethicon Endosurgery InScope tissue apposition system (TAS)., FDA regulation number 21 CFR 876.1500, CE#: CE0123 (G2S 09 12 57666 029)endoscopic suturing of the anastomotic leak | Device | open label treatment arm |
Primary outcome
Safety
Time frame: 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
Time frame: 2 years
Technical success of the anastomotic closure
2 secondary outcomes
Time to healing of the anastomotic leak
Time frame: 2 years
Long term safety
Time frame: 6 months after diagnosis of anastomotic leakage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annette Fritscher-Ravens, MD contact
Annette Fritscher-Ravens, MD principal investigator
UKSH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic suturing in people with Postoperative and Anastomosis, Surgical, run by University Hospital Schleswig-Holstein at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annette Fritscher-Ravens, MD (0049-431-597-2133), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2010.