Recruiting

STESD

Sponsor:

Shanghai Zhongshan Hospital

Code:

NCT03125733

Conditions

Zenker Diverticulum

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Submucosal tunneling endoscopic septum division

Study Details

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.

Conditions

Zenker Diverticulum

Study ID

NCT03125733

Start date

Jul 1, 2017

Status verified date

Aug, 2018

Completion date

Jun 14, 2019

Anticipated

Primary completion date

Jun 14, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: STESD

Submucosal tunneling endoscopic septum division

Interventions

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.

Primary outcome measure

  • Short-term change of symptom score [ Time Frame: 1 months after STESD ]
  • Peri-operative adverse events [ Time Frame: start of STESD to 30 days post-op ]

Central Contacts and Locations

Central contacts

Locations

NYU Winthrop Hospital

Recruiting

Mineola, New York, United States, 11501

Contacts

Principal Investigator:

Stavros N Stavropoulos, MD

More Information

Sponsor

Shanghai Zhongshan Hospital

Last update posted

Aug 3, 2018

Last verified

Aug, 2018

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Shanghai Zhongshan Hospital on 2018-08-03.