Esophageal stenosis has a high impact on patients quality of live and food intake affecting personal nutrition status and general health. For benign strictures of the esophagus, endoscopic dilatation therapy is recommended by actual guidelines. Since the extent of dilatation is currently directed by endoscopic view and fluoroscopic imaging, patients are exposed to radiation and the determination of the appropriate extent of dilatation is difficult. Therefore, the aim of this study is to compare the effect of 3D-planimetric measurement with current fluoroscopic monitoring on the success of endoscopic esophageal dilatation therapy in patients with benign esophageal stenosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
22
Esophageal stenosis is evaluated by 3D-planimetric measurement
Fluoroscopic control of dilatation therapy
Macroscopic endoscopic control of dilatation therapy
University Hospital Ulm, Clinic for Internal Medicine I
Ulm, Baden-Wuerttenberg, Germany
Endoscopic therapy success
Change in esophageal diameter \[mm\] and length of esophageal stricture \[cm\] after endoscopic therapy
Time frame: 3 months after intervention at endoscopic control examination
Length measurement of esophageal stenosis
Length measurement of esophageal stenosis by different methods \[cm\]
Time frame: during endoscopic intervention
Postinterventional esophageal diameter
Postinterventional esophageal diameter \[mm\]
Time frame: directly after endoscopic intervention
Hospitalization time after endoscopic dilatation therapy
Period of Hospitalization \[days\] after endoscopic dilatation therapy
Time frame: within 3 months after study intervention
Number of endoscopic interventions
Number of endoscopic interventions after study intervention
Time frame: within 3 months after study intervention
Number of hospitalizations due to complications
Hospitalization after study intervention \[number of events, days\] due to complications
Time frame: within 3 months after initial study intervention
Quality of life assessed by German Sydney Swallow Questionnaire
Quality of life according to the German Sydney Swallow Questionnaire (G-SWAL-QoL) questionnaire \[17 questions, minimum 0 to maximum 1700 points; higher score indicates higher impairment considering swallowing\]
Time frame: Baseline study intervention and 2 weeks after study intervention
Complication rate
Peri-procedural complication rate
Time frame: during the procedure
Duration of endoscopic examination
Duration of endoscopic examination \[minutes\]
Time frame: during the procedure
Sedation dose
Dose of sedative medication \[mg\] during study intervention
Time frame: during the procedure
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