Impact of 3D-planimetry on Optimized Therapeutic Assessment in Complex Benign Esophageal Stenosis (INTENSE)

Thomas Seufferlein

Status: Completed

Conditions: Benign Esophageal Stricture

Treatments: Radiation: Fluoroscopic control; Device: 3D-planimetric measurement; Diagnostic Test: Endoscopic control

Study type: Interventional

Funder types: Other

Identifiers

NCT07026357

UL001

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

3D-planimetric Measurement

Experimental group

Description:

Esophageal stenosis is measured and endoscopic therapy is controlled by 3D-planimetry in addition to the conventional method (fluoroscopy, endoscopic examination)

Treatment:

Diagnostic Test: Endoscopic control

Radiation: Fluoroscopic control

Device: 3D-planimetric measurement

Conventional Measurement

Active Comparator group

Description:

Esophageal stenosis is measured and endoscopic therapy is controlled by fluoroscopy and endoscopic examination only

Treatment:

Diagnostic Test: Endoscopic control

Radiation: Fluoroscopic control