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

August 2, 2018 updated by: Shanghai Zhongshan Hospital

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

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

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital, Fudan University
        • Contact:
        • Principal Investigator:
          • Ping-Hong Zhou, MD, PhD
        • Sub-Investigator:
          • Quan-Lin Li, MD
    • New York
      • Mineola, New York, United States, 11501
        • Recruiting
        • NYU Winthrop Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stavros N Stavropoulos, MD
        • Sub-Investigator:
          • Rani Modayil, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  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.

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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Anticipated)

June 14, 2019

Study Completion (Anticipated)

June 14, 2019

Study Registration Dates

First Submitted

April 16, 2017

First Submitted That Met QC Criteria

April 19, 2017

First Posted (Actual)

April 24, 2017

Study Record Updates

Last Update Posted (Actual)

August 3, 2018

Last Update Submitted That Met QC Criteria

August 2, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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