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

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.

Conditions

• Zenker Diverticulum

Interventions

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.

Sponsors & Collaborators

• Winthrop University Hospital

  collaborator OTHER

• Shanghai Zhongshan Hospital

  lead OTHER

Principal Investigators

• Ping-Hong Zhou, MD,PhD · Zhongshan Hospital, Fudan University, Shanghai, China

• Stavros N Stavropoulos, MD · NYU Winthrop Hospital, Mineola, NY, USA

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-01

Primary Completion

2019-06-14

Completion

2019-06-14

Countries

• United States
• China

Study Locations