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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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A Prospective International Multicenter Study on the Efficacy and Safety of Submucosal Tunneling Endoscopic Septum Division (STESD) for the Treatment of Zenker's Diverticulum

Conditions
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Zenker Diverticulum

Intervention / Treatment
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* Procedure: Submucosal tunneling endoscopic septum division


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STESD<br>Submucosal tunneling endoscopic septum division | Procedure: Submucosal tunneling endoscopic septum division<br>* STESD includes 4 steps: 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. 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. Septum Division: cricopharyngeal myotomy is performed longitudinally along the mid-line of the septum and ends in the normal esophageal muscle. Mucosal Closure: the mucosa incision, as well as any accidental mucosotomy if present, is closed with hemostatic clips.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term change of symptom score | 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 | 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 | 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 | 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 | 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 | Call for any additional treatment for Zenker's diverticulum is recorded at follow-up visits | 12 months after STESD | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapeutic, Endoscopy, Digestive system, Natural orifice transluminal endoscopic surgery, Complications