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出境医 / 临床实验 / Endoscopic Treatment for Zenker's Diverticulum
Endoscopic Treatment for Zenker's Diverticulum
Study Description
Brief Summary:
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Zenker Diverticulum | Procedure: Endoscopic septotomy |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 400 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Clinical Outcome of Endoscopic Treatment for Zenker's Diverticulum |
| Actual Study Start Date : | January 1, 2009 |
| Estimated Primary Completion Date : | December 30, 2028 |
| Estimated Study Completion Date : | December 30, 2028 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- Incidence of Adverse Events [ Time Frame: 24 hours after the procedure ]Any complications as bleeding, perforation, others
Secondary Outcome Measures :
- symptoms after the procedure [ Time Frame: up to 5 years ]The frequency of symptoms such as dysphagia, regurgitation, weight loss
Eligibility Criteria
Contacts and Locations
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 8, 2019 | ||||
| First Posted Date | May 14, 2019 | ||||
| Last Update Posted Date | August 28, 2020 | ||||
| Actual Study Start Date | January 1, 2009 | ||||
| Estimated Primary Completion Date | December 30, 2028 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Incidence of Adverse Events [ Time Frame: 24 hours after the procedure ] Any complications as bleeding, perforation, others
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
symptoms after the procedure [ Time Frame: up to 5 years ] The frequency of symptoms such as dysphagia, regurgitation, weight loss
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Endoscopic Treatment for Zenker's Diverticulum | ||||
| Official Title | Clinical Outcome of Endoscopic Treatment for Zenker's Diverticulum | ||||
| Brief Summary | 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | patients affected by ZD and treated by endoscopic procedures. | ||||
| Condition | Zenker Diverticulum | ||||
| Intervention | Procedure: Endoscopic septotomy
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)
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| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
400 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 30, 2028 | ||||
| Estimated Primary Completion Date | December 30, 2028 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
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| Listed Location Countries | Italy | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03948438 | ||||
| Other Study ID Numbers | ICH Zenker | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Istituto Clinico Humanitas | ||||
| Study Sponsor | Istituto Clinico Humanitas | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Istituto Clinico Humanitas | ||||
| Verification Date | August 2020 | ||||
