- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03125733
A New Treatment for Zenker's Diverticulum-submucosal Tunneling Endoscopic Septum Division (STESD)
A Prospective International Multicenter Study on the Efficacy and Safety of Submucosal Tunneling Endoscopic Septum Division (STESD) for the Treatment of Zenker's Diverticulum
Zenker's Diverticulum (ZD) is a sac-like outpouching of the lining of the esophageal wall at the upper esophagus. It is a rare disease typically seen in the middle-aged and older adults. Common symptoms of the disease include difficulties in swallowing (dysphagia), food reflux (regurgitation), unpleasant breath smells (halitosis) and couch, choking and hoarseness etc. (respiratory complications). Pills lodging in the sac and thus unable to take effect is also a common and yet often overlooked problem.
Traditional treatment for ZD included open resection done by head and neck surgeons and direct septum division done by ENT doctors. Septum division done by endoscopists is a new modality of treatment and so far has used the same approach as the ENT doctors-the wall between the sac and the normal esophageal lumen (the septum) is cut down directly so that food will not be held in the sac.
A cutting-edge endoscopic treatment for ZD is now emerging. In this approach, what we call submucosal tunneling endoscopic septum division (STESD), the wall is not cut directly, but inside a tunnel created by lifting the wallpaper (the mucosa lining the esophageal wall). After the muscle septum is completely cut, the mucosa is then sealed by clips, restoring integrity of the esophageal lining.
The advantage of STESD is twofold. First, the esophageal mucosa will be sealed after the operation, so that the chance of extravasation of luminal content with its relevant complications will be smaller. Second, under the protection of the tunnel, the endoscopist will be able to cut the septum completely down to its bottom, ensuring a more satisfactory symptom resolution. In short, our hypothesis is that treating Zenker's diverticulum by the tunneling endoscopic technique should be both safer and more effective than traditional methods.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients with symptomatic Zenker's diverticulum are considered for STESD. The diagnosis is based on clinical presentation, barium swallow, EGD and a swallow test to rule out other possible disorders causing cervical dysphagia. A scoring system (Costamagna, GIE, 2016) is used to evaluate severity of the symptoms. Four symptoms are evaluated: 1) dysphagia, 2) regurgitation, 3) daytime respiratory symptoms and 4) nighttime respiratory symptoms. These are scored based on a solid food diet according to the symptom frequency calculated within 2 consecutive weeks: 0-never, 1-1day/ week, 2-2~4days/ week, 3-≥5 days/ week. Under EGD and barium swallow test, configuration of the diverticulum is documented in detail (Shou-Jiang Tang, Laryngoscope, 2008). Quality of life is assessed using the SF-36 form. The pre- and post-STESD symptom score, quality of life score, and diverticulum configuration are compared.
Adverse events are recorded and graded according to the system suggested by the ASGE workshop (Cotton, GIE, 2010).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Quan-lin Li, MD
- Phone Number: +86-021-64041990
- Email: liquanlin321@126.com
Study Contact Backup
- Name: Xiao-Cen Zhang, MD
- Phone Number: +86-15000448731
- Email: xcezhang@gmail.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Recruiting
- Zhongshan Hospital, Fudan University
-
Contact:
- Quan-Lin Li, MD
- Phone Number: +85-021-64041990
- Email: liquanlin321@126.com
-
Principal Investigator:
- Ping-Hong Zhou, MD, PhD
-
Sub-Investigator:
- Quan-Lin Li, MD
-
-
-
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New York
-
Mineola, New York, United States, 11501
- Recruiting
- NYU Winthrop Hospital
-
Contact:
- Maria Kollarus, RN
- Phone Number: 516-663-4652
- Email: maria.kollarus@nyulangone.org
-
Contact:
- Wilmide Maignan
- Phone Number: +1(516)663-4623
- Email: WMaignan@nyuwinthrop.org
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Principal Investigator:
- Stavros N Stavropoulos, MD
-
Sub-Investigator:
- Rani Modayil, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of Zenker's diverticulum by symptoms, esophagram and/ or EGD
- Symptomatic score≥2 in any of the symptoms or ≥3 in total
- Patients or legal surrogates willing and competent to give informed consent and to comply with follow up visits and tests
Exclusion Criteria:
- Patients with minimal symptoms (score ≤1 in all four symptoms and <3 in total)
- Presence of coagulopathy or pregnancy
- Patients who, in the investigator's opinion, are medically unstable or have a life expectancy of< 2 years, are unable to give informed consent or have poor compliance with follow-up, or whose risks of participating in the study outweigh the benefits
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: STESD
Submucosal tunneling endoscopic septum division
|
STESD includes 4 steps:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short-term change of symptom score
Time Frame: 1 months after STESD
|
Symptoms for Zenker's diverticulum are scored at follow-up visits and compared with pre-STESD value
|
1 months after STESD
|
Peri-operative adverse events
Time Frame: start of STESD to 30 days post-op
|
Details and grading for any adverse event as defined by the ASGE lexicon are recorded during the peri-operative period
|
start of STESD to 30 days post-op
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mid-term change of symptom score
Time Frame: 12 months after STESD
|
Symptoms for Zenker's diverticulum are evaluated at follow-up visit and compared to pre-STESD value
|
12 months after STESD
|
Change of diverticulum size under EGD
Time Frame: 1 months after STESD
|
ESD is done at follow-up visit and configuration of the diverticulum is compared to that pre-STESD
|
1 months after STESD
|
Change of diverticulum size under esophagram
Time Frame: 1 months after STESD
|
Barium esophagram is done at follow-up visit and configuration of the diverticulum is compared to that pre-STESD
|
1 months after STESD
|
Call for other treatments, such as repeat myotomy
Time Frame: 12 months after STESD
|
Call for any additional treatment for Zenker's diverticulum is recorded at follow-up visits
|
12 months after STESD
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in quality of life score
Time Frame: Baseline and 12 months after STESD
|
Patients' quality of life is recorded by using the SF-36 system
|
Baseline and 12 months after STESD
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Ping-Hong Zhou, MD,PhD, Zhongshan Hospital, Fudan University, Shanghai, China
- Study Director: Stavros N Stavropoulos, MD, NYU Winthrop Hospital, Mineola, NY, USA
Publications and helpful links
General Publications
- Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.
- Costamagna G, Iacopini F, Bizzotto A, Familiari P, Tringali A, Perri V, Bella A. Prognostic variables for the clinical success of flexible endoscopic septotomy of Zenker's diverticulum. Gastrointest Endosc. 2016 Apr;83(4):765-73. doi: 10.1016/j.gie.2015.08.044. Epub 2015 Sep 3.
- Tang SJ, Jazrawi SF, Chen E, Tang L, Myers LL. Flexible endoscopic clip-assisted Zenker's diverticulotomy: the first case series (with videos). Laryngoscope. 2008 Jul;118(7):1199-205. doi: 10.1097/MLG.0b013e31816e2eee.
- Gutschow CA, Hamoir M, Rombaux P, Otte JB, Goncette L, Collard JM. Management of pharyngoesophageal (Zenker's) diverticulum: which technique? Ann Thorac Surg. 2002 Nov;74(5):1677-82; discussion 1682-3. doi: 10.1016/s0003-4975(02)03931-0.
- Ferreira LE, Simmons DT, Baron TH. Zenker's diverticula: pathophysiology, clinical presentation, and flexible endoscopic management. Dis Esophagus. 2008;21(1):1-8. doi: 10.1111/j.1442-2050.2007.00795.x.
- Law R, Katzka DA, Baron TH. Zenker's Diverticulum. Clin Gastroenterol Hepatol. 2014 Nov;12(11):1773-82; quiz e111-2. doi: 10.1016/j.cgh.2013.09.016. Epub 2013 Sep 18.
- Li QL, Chen WF, Zhang XC, Cai MY, Zhang YQ, Hu JW, He MJ, Yao LQ, Zhou PH, Xu MD. Submucosal Tunneling Endoscopic Septum Division: A Novel Technique for Treating Zenker's Diverticulum. Gastroenterology. 2016 Dec;151(6):1071-1074. doi: 10.1053/j.gastro.2016.08.064. Epub 2016 Sep 21. No abstract available.
- Vigneswaran Y, Tanaka R, Gitelis M, Carbray J, Ujiki MB. Quality of life assessment after peroral endoscopic myotomy. Surg Endosc. 2015 May;29(5):1198-202. doi: 10.1007/s00464-014-3793-2. Epub 2014 Sep 24.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STESD for Zenker
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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