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Use of novel device in the endoscopic treatment of Zenker's Diverticulum patients

Functional Lumen Imaging Probe demonstrates reduced cricopharyngeal distensibility and myotomy-induced improvement in Zenker’s Diverticulum patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12620000410954
Enrollment
11
Registered
2020-03-27
Start date
2018-12-03
Completion date
2018-12-28
Last updated
2020-04-06

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

Conditions

None listed

Brief summary

Zenker diverticulum is a herniation of the oesophageal mucosa resulting in pouch formation which can result in dysphagia and spontaneous regurgitation. Treatment with flexible endoscopic myotomy demonstrates lower morbidity compared to previous modalities. However, there is no established standard approach with unknown optimal technique. While the principal is to cut the cricopharyngeal muscle, a careful balance needs to be achieved to not cause perforation, while noting that an incomplete myotomy leads to higher recurrence rates. Intra-procedural measurement of distensibility across the Zenker's using the endoscopic Functional Lumen Imaging Probe (FLIP) could allow real-time determination of whether further incision will be required. Through retrospective review of medical records we hope to determine the feasibility of intra-procedural FLIP measurements in these patients, and assess whether there is a correlation between changes of distensibility following myotomy with symptoms and pouch size. We expect approximately 10 patients and hope to show that intra-procedural measurements will help to guide extent of myotomy to minimise risk of perforation as well as recurrence.

Interventions

FLIP (functional lumen imaging probe) measures intestinal distensibility measurements. It has been used in a variety of clinical applications, and has previously been shown to discriminate outcomes from treatment of other oesophageal pathologies including achalasia and oesophageal strictures. At our facility, FLIP measurements were performed pre- and post-therapeutic endoscopy procedures for dysphagic patients as part of standard care. This includes Zenker patients as well as patients with beni

FLIP (functional lumen imaging probe) measures intestinal distensibility measurements. It has been used in a variety of clinical applications, and has previously been shown to discriminate outcomes from treatment of other oesophageal pathologies including achalasia and oesophageal strictures. At our facility, FLIP measurements were performed pre- and post-therapeutic endoscopy procedures for dysphagic patients as part of standard care. This includes Zenker patients as well as patients with benign oesophageal strictures and achalasia. For Zenker patients as relevant to our study, FLIP measurements will be performed during flexible endoscopy cricopharyngeal myotomy. Measurements will be performed by a senior gastroenterologist with expertise in oesophageal pathologies and advanced endoscopic techniques. Patients will be anaesthetised during the procedure by an anaesthesiologist(as is standard for endoscopic myotomy) and FLIP measurements will be taken immediately pre- and post-myotomy. FLIP measurements add approximately 10 minutes to procedure length, and will be performed as a single assessment during the procedure.

Sponsors

Linda Zhang
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Treatment naive Zenker's diverticulum patients undergoing flexible endoscopic cricopharyngeal myotomy

Exclusion criteria

Patients without radiologically proven presence of Zenker diverticulum. Patients who have previously had endoscopic or surgical treatment of Zenker diverticulum

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026