Pilot study for the introduction of standardized, pretherapeutic endoscopy, possibly with marker implantation (Visicoil), in patients with esophageal carcinoma eligible for primary therapy with curative intent at UCC Dresden

Pilot study for the introduction of standardized, pretherapeutic endoscopy, possibly with marker implantation (Visicoil), in patients with esophageal carcinoma eligible for primary therapy with curative intent at UCC Dresden - EVI

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00011886

Enrollment

Registered

2017-05-31

Start date

2017-07-27

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C15.1 C15.2 C15.3 C15.4 C15.5 C15.8

Interventions

Group 1: Endoscopy and possibly endoscopy-supported implantation of Fiducial Goldmarkers (Visicoil®) in patients with esophageal carcinoma prior to performing routine FDG PET CT imaging.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • histologically confirmed tumor • Patients with cT2 N0 M0 tumors that are suitable for primary resection • Patients with cT2-4 N + M0 tumors suitable for neoadjuvant radiochemotherapy (41.4 Gy) followed by resection • Patients with cT2-4 N + M0 tumors that are eligible for primary radiochemotherapy due to co-morbidities or patient requirements • Complete stenosis of the esophagus was excluded • written patient consent

Exclusion criteria

Exclusion criteria: • Presence of distant metastases • Patients who are not suitable for curative treatment

Design outcomes

Primary

Measure	Time frame
Implementation of endoscopy with possible gold marker implantation as a feasible, safe, pretherapeutic diagnostic method.	—

Secondary

Measure	Time frame
• Toxicity / AE (CTCAE 4.0) after implantation of the “Visicoil” markers • Number and position of the injected Markers • Visibility of the markers and their geometrical stability prior to and during treatment on routinely performed FDG-PET/CT imaging and on weekly control-CT in patients undergoing proton irradiation.	—

Countries

Germany

Contacts

Public ContactAnnett Klöber

Universitätsklinikum Dresden, Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinisches Studienzentrum

str.studien@uniklinikum-dresden.de0351-458 13390

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 6, 2026