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A New Treatment for Zenker's Diverticulum-submucosal Tunneling Endoscopic Septum Division (STESD)

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ClinicalTrials.gov Identifier: NCT03125733
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : August 3, 2018
Sponsor:
Collaborator:
Winthrop University Hospital
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Zenker Diverticulum Procedure: Submucosal tunneling endoscopic septum division Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective International Multicenter Study on the Efficacy and Safety of Submucosal Tunneling Endoscopic Septum Division (STESD) for the Treatment of Zenker's Diverticulum
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : June 14, 2019
Estimated Study Completion Date : June 14, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: STESD
Submucosal tunneling endoscopic septum division
Procedure: Submucosal tunneling endoscopic septum division

STESD includes 4 steps:

  1. Mucosal incision: submucosal injection of normal saline-indigo carmine solution is performed 2-3cm proximal to the diverticular septum and a 1.5-2cm longitudinal mucosal incision is made using the endoscopic knife.
  2. Submucosal tunneling: a submucosal tunnel is created using the same technique as applied by Peroral Endoscopic Myotomy (POEM) at both sides of the septum until 1-2cm distal to the bottom of the diverticulum.
  3. Septum Division: cricopharyngeal myotomy is performed longitudinally along the mid-line of the septum and ends in the normal esophageal muscle.
  4. Mucosal Closure: the mucosa incision, as well as any accidental mucosotomy if present, is closed with hemostatic clips.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125733


Contacts
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Contact: Quan-Lin Li, MD +86-021-64041990 liquanlin321@126.com
Contact: Xiao-Cen Zhang, MD +86-15000448731 xcezhang@gmail.com

Locations
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United States, New York
NYU Winthrop Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Maria Kollarus, RN    516-663-4652    maria.kollarus@nyulangone.org   
Contact: Wilmide Maignan    +1(516)663-4623    WMaignan@nyuwinthrop.org   
Principal Investigator: Stavros N Stavropoulos, MD         
Sub-Investigator: Rani Modayil, MD         
China, Shanghai
Zhongshan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Quan-Lin Li, MD    +85-021-64041990    liquanlin321@126.com   
Principal Investigator: Ping-Hong Zhou, MD, PhD         
Sub-Investigator: Quan-Lin Li, MD         
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Winthrop University Hospital
Investigators
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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:

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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT03125733     History of Changes
Other Study ID Numbers: STESD for Zenker
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Zhongshan Hospital:
Endoscopy, Digestive system
Natural orifice transluminal endoscopic surgery
Therapeutic
Complications
Additional relevant MeSH terms:
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Diverticulum
Diverticular Diseases
Zenker Diverticulum
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical
Diverticulum, Esophageal