Impact of 3D-planimetry on Optimized Therapeutic Assessment in Complex Benign Esophageal Stenosis
NCT ID: NCT07026357
Last Updated: 2025-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2022-12-28
2024-03-27
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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3D-planimetric Measurement
Esophageal stenosis is measured and endoscopic therapy is controlled by 3D-planimetry in addition to the conventional method (fluoroscopy, endoscopic examination)
3D-planimetric measurement
Esophageal stenosis is evaluated by 3D-planimetric measurement
Fluoroscopic control
Fluoroscopic control of dilatation therapy
Endoscopic control
Macroscopic endoscopic control of dilatation therapy
Conventional Measurement
Esophageal stenosis is measured and endoscopic therapy is controlled by fluoroscopy and endoscopic examination only
Fluoroscopic control
Fluoroscopic control of dilatation therapy
Endoscopic control
Macroscopic endoscopic control of dilatation therapy
Interventions
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3D-planimetric measurement
Esophageal stenosis is evaluated by 3D-planimetric measurement
Fluoroscopic control
Fluoroscopic control of dilatation therapy
Endoscopic control
Macroscopic endoscopic control of dilatation therapy
Eligibility Criteria
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Inclusion Criteria
* medical indication for endoscopic therapy
* written consent after detailed information
Exclusion Criteria
* missing written consent
* trans-oral endoscopic access is not possible
* medical contraindication for endoscopic dilatation therapy
* age \<18 years
18 Years
ALL
No
Sponsors
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University Hospital Tuebingen
OTHER
University Hospital Augsburg
OTHER
University Hospital Munich
OTHER
Thomas Seufferlein
OTHER
Responsible Party
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Thomas Seufferlein
Prof. Dr.
Principal Investigators
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Benjamin Walter, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Ulm
Locations
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University Hospital Ulm, Clinic for Internal Medicine I
Ulm, Baden-Wuerttenberg, Germany
Countries
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Other Identifiers
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UL001
Identifier Type: -
Identifier Source: org_study_id
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