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

NCT03125733 | Unknown

• 1 other identifier: STESD for Zenker
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Mid-term change of symptom score

  12 months after STESD

• Change of diverticulum size under EGD

  1 months after STESD

• Change of diverticulum size under esophagram

  1 months after STESD

• Call for other treatments, such as repeat myotomy

  12 months after STESD

Other Outcomes (1)

• Changes in quality of life score

  Baseline and 12 months after STESD

Study Arms (1)

STESD

EXPERIMENTAL

Submucosal tunneling endoscopic septum division

Procedure: Submucosal tunneling endoscopic septum division

Interventions

Submucosal tunneling endoscopic septum division PROCEDURE

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.

STESD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Winthrop University Hospital: collaborator

Study Sites (2)

NYU Winthrop Hospital

Mineola, New York, 11501, United States

RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (8)

• Costamagna G, Iacopini F, Bizzotto A, Familiari P, Tringali A, Perri V, Bella A. Prognostic variables for the clinical success of flexible endoscopic septotomy of Zenker's diverticulum. Gastrointest Endosc. 2016 Apr;83(4):765-73. doi: 10.1016/j.gie.2015.08.044. Epub 2015 Sep 3.

  PMID: 26344886 BACKGROUND

• Tang SJ, Jazrawi SF, Chen E, Tang L, Myers LL. Flexible endoscopic clip-assisted Zenker's diverticulotomy: the first case series (with videos). Laryngoscope. 2008 Jul;118(7):1199-205. doi: 10.1097/MLG.0b013e31816e2eee.

  PMID: 18401278 BACKGROUND

• Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.

  PMID: 20189503 BACKGROUND

• Gutschow CA, Hamoir M, Rombaux P, Otte JB, Goncette L, Collard JM. Management of pharyngoesophageal (Zenker's) diverticulum: which technique? Ann Thorac Surg. 2002 Nov;74(5):1677-82; discussion 1682-3. doi: 10.1016/s0003-4975(02)03931-0.

  PMID: 12440629 BACKGROUND

• Ferreira LE, Simmons DT, Baron TH. Zenker's diverticula: pathophysiology, clinical presentation, and flexible endoscopic management. Dis Esophagus. 2008;21(1):1-8. doi: 10.1111/j.1442-2050.2007.00795.x.

  PMID: 18197932 BACKGROUND

• Law R, Katzka DA, Baron TH. Zenker's Diverticulum. Clin Gastroenterol Hepatol. 2014 Nov;12(11):1773-82; quiz e111-2. doi: 10.1016/j.cgh.2013.09.016. Epub 2013 Sep 18.

  PMID: 24055983 BACKGROUND

• Li QL, Chen WF, Zhang XC, Cai MY, Zhang YQ, Hu JW, He MJ, Yao LQ, Zhou PH, Xu MD. Submucosal Tunneling Endoscopic Septum Division: A Novel Technique for Treating Zenker's Diverticulum. Gastroenterology. 2016 Dec;151(6):1071-1074. doi: 10.1053/j.gastro.2016.08.064. Epub 2016 Sep 21. No abstract available.

  PMID: 27664512 BACKGROUND

• Vigneswaran Y, Tanaka R, Gitelis M, Carbray J, Ujiki MB. Quality of life assessment after peroral endoscopic myotomy. Surg Endosc. 2015 May;29(5):1198-202. doi: 10.1007/s00464-014-3793-2. Epub 2014 Sep 24.

  PMID: 25249144 BACKGROUND

MeSH Terms

Conditions

Zenker Diverticulum

Condition Hierarchy (Ancestors)

Diverticulum, Esophageal; Diverticulum; Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ping-Hong Zhou, MD,PhD

  Zhongshan Hospital, Fudan University, Shanghai, China

  STUDY CHAIR

• Stavros N Stavropoulos, MD

  NYU Winthrop Hospital, Mineola, NY, USA

  STUDY DIRECTOR

Central Study Contacts

Quan-Lin Li, MD

CONTACT

+86-021-64041990; liquanlin321@126.com

Xiao-Cen Zhang, MD

CONTACT

+86-15000448731; xcezhang@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2017
• First Posted: April 24, 2017
• Study Start: July 1, 2017
• Primary Completion: June 14, 2019
• Study Completion: June 14, 2019
• Last Updated: August 3, 2018

Record last verified: 2018-08

Locations

CN (1); US (1)