Benign Esophageal Stricture
Conditions
Brief summary
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.
Interventions
DEVICE3D-planimetric measurement
Esophageal stenosis is evaluated by 3D-planimetric measurement
RADIATIONFluoroscopic control
Fluoroscopic control of dilatation therapy
DIAGNOSTIC_TESTEndoscopic control
Macroscopic endoscopic control of dilatation therapy
Sponsors
University Hospital Tuebingen
University Hospital Augsburg
University Hospital Munich
Thomas Seufferlein
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* symptomatic benign esophageal stenosis * medical indication for endoscopic therapy * written consent after detailed information
Exclusion criteria
* non-benign esophageal stenosis * missing written consent * trans-oral endoscopic access is not possible * medical contraindication for endoscopic dilatation therapy * age \<18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopic therapy success | 3 months after intervention at endoscopic control examination | Change in esophageal diameter \[mm\] and length of esophageal stricture \[cm\] after endoscopic therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postinterventional esophageal diameter | directly after endoscopic intervention | Postinterventional esophageal diameter \[mm\] |
| Hospitalization time after endoscopic dilatation therapy | within 3 months after study intervention | Period of Hospitalization \[days\] after endoscopic dilatation therapy |
| Number of endoscopic interventions | within 3 months after study intervention | Number of endoscopic interventions after study intervention |
| Number of hospitalizations due to complications | within 3 months after initial study intervention | Hospitalization after study intervention \[number of events, days\] due to complications |
| Length measurement of esophageal stenosis | during endoscopic intervention | Length measurement of esophageal stenosis by different methods \[cm\] |
| Complication rate | during the procedure | Peri-procedural complication rate |
| Duration of endoscopic examination | during the procedure | Duration of endoscopic examination \[minutes\] |
| Sedation dose | during the procedure | Dose of sedative medication \[mg\] during study intervention |
| Quality of life assessed by German Sydney Swallow Questionnaire | Baseline study intervention and 2 weeks after study intervention | Quality of life according to the German Sydney Swallow Questionnaire (G-SWAL-QoL) questionnaire \[17 questions, minimum 0 to maximum 1700 points; higher score indicates higher impairment considering swallowing\] |
Countries
Germany
Outcome results
None listed