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Procedure

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

N/A
Waitlist Available
Research Sponsored by Shanghai Zhongshan Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 months after stesd
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Zenker Diverticulum

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 months after stesd
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 months after stesd for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Peri-operative adverse events
Short-term change of symptom score
Secondary study objectives
Call for other treatments, such as repeat myotomy
Change of diverticulum size under EGD
Change of diverticulum size under esophagram
+1 more
Other study objectives
Changes in quality of life score

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: STESDExperimental Treatment1 Intervention
Submucosal tunneling endoscopic septum division

Find a Location

Who is running the clinical trial?

Shanghai Zhongshan HospitalLead Sponsor
646 Previous Clinical Trials
2,509,043 Total Patients Enrolled
Winthrop University HospitalOTHER
58 Previous Clinical Trials
48,934 Total Patients Enrolled
Ping-Hong Zhou, MD,PhDStudy ChairZhongshan Hospital, Fudan University, Shanghai, China
4 Previous Clinical Trials
961 Total Patients Enrolled
Stavros N Stavropoulos, MDStudy DirectorNYU Winthrop Hospital, Mineola, NY, USA
1 Previous Clinical Trials
120 Total Patients Enrolled
~2 spots leftby Dec 2025