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| Name | Class |
|---|---|
| University Hospital Tuebingen | OTHER |
| University Hospital Augsburg | OTHER |
| University Hospital Munich | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D-planimetric Measurement | Experimental | Esophageal stenosis is measured and endoscopic therapy is controlled by 3D-planimetry in addition to the conventional method (fluoroscopy, endoscopic examination) |
|
| Conventional Measurement | Active Comparator | Esophageal stenosis is measured and endoscopic therapy is controlled by fluoroscopy and endoscopic examination only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D-planimetric measurement | Device | Esophageal stenosis is evaluated by 3D-planimetric measurement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic therapy success | Change in esophageal diameter [mm] and length of esophageal stricture [cm] after endoscopic therapy | 3 months after intervention at endoscopic control examination |
| Measure | Description | Time Frame |
|---|---|---|
| Length measurement of esophageal stenosis | Length measurement of esophageal stenosis by different methods [cm] | during endoscopic intervention |
| Postinterventional esophageal diameter | Postinterventional esophageal diameter [mm] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Walter, PhD | University Hospital Ulm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ulm, Clinic for Internal Medicine I | Ulm | Baden-Wuerttenberg | 89081 | Germany |
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| Fluoroscopic control | Radiation | Fluoroscopic control of dilatation therapy |
|
| Endoscopic control | Diagnostic Test | Macroscopic endoscopic control of dilatation therapy |
|
| directly after endoscopic intervention |
| Hospitalization time after endoscopic dilatation therapy | Period of Hospitalization [days] after endoscopic dilatation therapy | within 3 months after study intervention |
| Number of endoscopic interventions | Number of endoscopic interventions after study intervention | within 3 months after study intervention |
| Number of hospitalizations due to complications | Hospitalization after study intervention [number of events, days] due to complications | 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] | Baseline study intervention and 2 weeks after study intervention |
| Complication rate | Peri-procedural complication rate | during the procedure |
| Duration of endoscopic examination | Duration of endoscopic examination [minutes] | during the procedure |
| Sedation dose | Dose of sedative medication [mg] during study intervention | during the procedure |