Impact of Endo-vac Therapy for Esophago-jejunal Anastomotic Leak
ConditionEsophagojejunal Anastomotic Leak
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorUkrainian Society of Clinical Oncology
About this trial
The goal of this observational study is to assess the impact of endoscopic vacuum therapy in patients who underwent total gastrectomy due to gastric cancer and developed esophago-jejunal anastomotic leakage. The main outcomes to be investigated are the following:
Primary endpoint: mortality rate Secondary endpoints: morbidity rate, time from AL diagnosis to discharge, patients satisfactory rate.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients who developed esophago-jejunal anastomotic leak less than 50% of circumference of anastomosis
patients who developed esophago-jejunal anastomotic leak and remained stable at the moment of diagnosis with no indications for diversion surgery
Disqualifiers
unstable patients who developed esophago-jejunal anastomotic leak
patients who developed esophago-jejunal anastomotic leak more than 50% or anastomotic circumference
patients who rejected endoscopic vacuum therapy
Trial population
Study population involves ukrainian patients who developed esophago-jejunal anastomotic leak after total gastrectomy due to gastric cancer
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Endo-vac cohort
Trial outcomes
Primary outcomes
1
Mortality rate
Mortality rate associated with endoscopic vacuum therapy
Time frame
90 days after last endo-vac placementSecondary outcomes
1
Morbidity rate
Rate of complications associated with endoscopic vacuum therapy or ineffective local control
Time frame
90 days after last endoscopic vacuum placement2
Time from AL diagnosis to discharge
time from AL diagnosis to discharge
Time frame
The number of days from from AL diagnosis to discharge3
Patients satisfactory rate
Patients satisfactory rate assessed by quality of life questionnaires and patient-reported outcomes scales
Time frame
90 days after discharge, 365 days after discharge, 2/3/4/5 years after dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov