Endoscopic Treatment of Zenker's Diverticulum (ZENKTUN)

Launched by SOCIÉTÉ FRANÇAISE D'ENDOSCOPIE DIGESTIVE · Sep 10, 2024

Keywords

ClinConnect Summary

The ZENKTUN clinical trial is studying two different treatment methods for a condition called Zenker's diverticulum, which can cause swallowing difficulties. Specifically, the trial is comparing a technique called Tunnelization (Z-POEM) with other traditional methods that don’t involve tunnelization. The main goal is to see how many patients experience a return of their symptoms one year after receiving treatment.

To participate in this trial, you must be at least 18 years old and have symptoms of Zenker's diverticulum, which can be evaluated using certain tests. However, there are some people who cannot join, including those under 18, pregnant women, and those with serious health issues or previous treatments for this condition. The study is still in the planning stages and has not started recruiting participants yet, but if you qualify, you can expect to receive one of the two treatment methods and be monitored for symptom changes over the course of a year.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with symptomatic Zenker's diverticulum (Augsburg score ≥5 )
• • Diagnostic evaluation including esophagogastroduodenoscopy (EGD) and a barium swallow (TOGD) with measurement of the diverticulum's height.
• • Patient aged 18 years or older
• • Patient with ASA 1, ASA 2, ASA 3 status
• • No participation in another concurrent clinical study
• Exclusion Criteria:
• • Patient under 18 years old
• • Patient with ASA 4 or ASA 5 status
• • Pregnant woman
• • Patient with coagulation disorders preventing the performance a polypectomy: PT \< 50%, Platelets \< 50,000/mm³, ongoing effective anticoagulation, or current clopidogrel use.
• • Patient who has already undergone initial endoscopic or surgical treatment for Zenker's diverticulum