A New Treatment for Zenker's Diverticulum-submucosal Tunneling Endoscopic Septum Division
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/5/2018 |
| Start Date: | July 1, 2017 |
| End Date: | June 14, 2019 |
| Contact: | Quan-Lin Li, MD |
| Email: | liquanlin321@126.com |
| Phone: | +86-021-64041990 |
A Prospective International Multicenter Study on the Efficacy and Safety of Submucosal Tunneling Endoscopic Septum Division (STESD) for the Treatment of Zenker's Diverticulum
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.
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.
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).
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).
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
We found this trial at
2
sites
111 Yixueyuan Road
Shanghai, Shanghai 20003
Shanghai, Shanghai 20003
Principal Investigator: Ping-Hong Zhou, MD, PhD
Phone: +85-021-64041990
Click here to add this to my saved trials
259 1st Street
Mineola, New York 11501
Mineola, New York 11501
Principal Investigator: Stavros N Stavropoulos, MD
Phone: 516-663-4652
Click here to add this to my saved trials