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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 eff

Detailed Summary:

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).

Sponsor: Shanghai Zhongshan Hospital

Current Primary Outcome:

• 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
• 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

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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
• 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
• 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
• 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

Original Secondary Outcome: Same as current

Information By: Shanghai Zhongshan Hospital

Dates:
Date Received: April 16, 2017
Date Started: May 25, 2017
Date Completion: May 14, 2019
Last Updated: April 27, 2017
Last Verified: April 2017