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Zenker's diverticulum (ZD) is a rare benign condition, due to an acquired sac-like outpouching of the mucosa and submucosa layers originating from the pharyngoesophageal junction. Endoscopic techniques like flexible endoscopic septum division (FESD) or per-oral endoscopic septotomy (POES), represent a minimally invasive alternative to surgery or to rigid endoscopic procedure to treat ZD. The goal of the research will be to evaluate the safety of the procedures and to measure Zenker-symptom severity in all patients treated by endoscopic procedures.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic septotomy | Procedure | Patients will be placed in left lateral decubitus position, either in conscious sedation or under deep sedation with propofol or endotracheal intubation.The procedure will be performed with a flexible standard endoscope and started with initial endoscopic examination with suction of possible retained material insidethe diverticulum. An incision of the bridge between the ZD and the esophagus will be done (using one endoscopic procedure as POES or FESD or other) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Any complications as bleeding, perforation, others | 24 hours after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| symptoms after the procedure | The frequency of symptoms such as dysphagia, regurgitation, weight loss | up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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patients affected by ZD and treated by endoscopic procedures.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alessandro Repici, Prof. | Contact | alessandro.repici@hunimed.eu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanitas Research Hospital | Recruiting | Rozzano | 20089 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34236338 | Derived | Repici A, Cappello A, Spadaccini M, Nicoletti R, Carrara S, Fugazza A, Galtieri PA, Lamonaca L, Romana C, Badalamenti M, Di Leo M, Pellegatta G, Ferrara EC, Anderloni A, Maselli R. Cap-Assisted Endoscopic Septotomy of Zenker's Diverticulum: Early and Long-Term Outcomes. Am J Gastroenterol. 2021 Sep 1;116(9):1853-1858. doi: 10.14309/ajg.0000000000001356. |
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| ID | Term |
|---|---|
| D016672 | Zenker Diverticulum |
| ID | Term |
|---|---|
| D004936 | Diverticulum, Esophageal |
| D004240 | Diverticulum |
| D000076385 | Diverticular Diseases |
| D005759 | Gastroenteritis |
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| D005767 |
| Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |