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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03125733
Acronym
STESD
Enrollment
20
Registered
2017-04-24
Start date
2017-07-01
Completion date
2019-06-14
Last updated
2018-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Zenker Diverticulum

Keywords

Endoscopy, Digestive system, Natural orifice transluminal endoscopic surgery, Therapeutic, Complications

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 effective than traditional methods.

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).

Interventions

PROCEDURESubmucosal 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

Winthrop University Hospital
CollaboratorOTHER
Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Peri-operative adverse eventsstart of STESD to 30 days post-opDetails and grading for any adverse event as defined by the ASGE lexicon are recorded during the peri-operative period
Short-term change of symptom score1 months after STESDSymptoms for Zenker's diverticulum are scored at follow-up visits and compared with pre-STESD value

Secondary

MeasureTime frameDescription
Change of diverticulum size under EGD1 months after STESDESD is done at follow-up visit and configuration of the diverticulum is compared to that pre-STESD
Call for other treatments, such as repeat myotomy12 months after STESDCall for any additional treatment for Zenker's diverticulum is recorded at follow-up visits
Change of diverticulum size under esophagram1 months after STESDBarium esophagram is done at follow-up visit and configuration of the diverticulum is compared to that pre-STESD
Mid-term change of symptom score12 months after STESDSymptoms for Zenker's diverticulum are evaluated at follow-up visit and compared to pre-STESD value

Other

MeasureTime frameDescription
Changes in quality of life scoreBaseline and 12 months after STESDPatients' quality of life is recorded by using the SF-36 system

Countries

China, United States

Contacts

Primary ContactQuan-Lin Li, MD
liquanlin321@126.com+86-021-64041990
Backup ContactXiao-Cen Zhang, MD
xcezhang@gmail.com+86-15000448731

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026