Zenker DiverticulumSTESDNCT03125733
A New Treatment for Zenker's Diverticulum-submucosal Tunneling Endoscopic Septum Division
A study testing Submucosal tunneling endoscopic septum division in people with Zenker Diverticulum, run by Shanghai Zhongshan Hospital at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Zenker Diverticulum
- What is being tested?
- Submucosal tunneling endoscopic septum division
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jul 2017to 14 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
NYU Winthrop Hospital
Mineola, New York, 11501
Maria Kollarus, RN, 516-663-4652, maria.kollarus@nyulangone.org
Wilmide Maignan, +1(516)663-4623, WMaignan@nyuwinthrop.org
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Quan-Lin Li, MD, +85-021-64041990, liquanlin321@126.com
Ping-Hong Zhou, MD, PhD
About this study
Official title: 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.
Read more
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.
Read the 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).
- Conditions
- Zenker Diverticulum
- Being tested
- Submucosal tunneling endoscopic septum division
- Keywords
- Endoscopy, Digestive system, Natural orifice transluminal endoscopic surgery, Therapeutic, Complications
- Medical subject headings
- Zenker Diverticulum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Submucosal tunneling endoscopic septum divisionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| STESD | Experimental | Submucosal tunneling endoscopic septum division Receives: Procedure: Submucosal tunneling endoscopic septum division |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term change of symptom score
Symptoms for Zenker's diverticulum are scored at follow-up visits and compared with pre-STESD value
Measured: 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
Measured: start of STESD to 30 days post-op
Secondary outcomes (4)
Mid-term change of symptom score
Symptoms for Zenker's diverticulum are evaluated at follow-up visit and compared to pre-STESD value
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months after STESD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start1 Jul 2017
- Primary completion14 Jun 2019 (estimated)
- Study completion14 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Zenker DiverticulumStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Winthrop University Hospital
- Responsible party
- Sponsor
- Investigators
- Ping-Hong Zhou, MD,PhD, Study chair, Zhongshan Hospital, Fudan University, Shanghai, ChinaStavros N Stavropoulos, MD, Study director, NYU Winthrop Hospital, Mineola, NY, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125733
- Sponsor's protocol ID
- STESD for Zenker
- Acronym
- STESD
- Status last verified
- Aug 2018
- First submitted
- 16 Apr 2017
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26344886Tang 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.
PubMed 18401278Cotton 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.
PubMed 20189503Gutschow 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.
PubMed 12440629Ferreira 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.
PubMed 18197932Law 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.
PubMed 24055983Li 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.
PubMed 27664512Vigneswaran 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.
PubMed 25249144
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective International Multicenter Study on the Efficacy and Safety of Submucosal Tunneling Endoscopic Septum Division (STESD) for the Treatment of Zenker's Diverticulum
- ClinicalTrials.gov ID
- NCT03125733
- Acronym / sponsor ID
- STESD / STESD for Zenker
- Conditions
- Zenker Diverticulum
- Keywords
- Endoscopy, Digestive system, Natural orifice transluminal endoscopic surgery, Therapeutic, Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Winthrop University Hospital
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 14 Jun 2019 (estimated)
- Study completion
- 14 Jun 2019 (estimated)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STESD | Experimental | Procedure: Submucosal tunneling endoscopic septum divisionSubmucosal tunneling endoscopic septum division |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Submucosal tunneling endoscopic septum divisionSTESD 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. | Procedure or surgery | STESD |
Primary outcome
Short-term change of symptom score
Time frame: 1 months after STESD
Symptoms for Zenker's diverticulum are scored at follow-up visits and compared with pre-STESD value
Peri-operative adverse events
Time frame: start of STESD to 30 days post-op
Details and grading for any adverse event as defined by the ASGE lexicon are recorded during the peri-operative period
4 secondary outcomes
Mid-term change of symptom score
Time frame: 12 months after STESD
Change of diverticulum size under EGD
Time frame: 1 months after STESD
Change of diverticulum size under esophagram
Time frame: 1 months after STESD
Call for other treatments, such as repeat myotomy
Time frame: 12 months after STESD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Background: PubMed 26344886Costamagna 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.
- Background: PubMed 18401278Tang 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.
- Background: PubMed 20189503Cotton 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.
- Background: PubMed 12440629Gutschow 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.
- Background: PubMed 18197932Ferreira 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.
- Background: PubMed 24055983Law 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.
- Background: PubMed 27664512Li 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.
- Background: PubMed 25249144Vigneswaran 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ping-Hong Zhou, MD,PhD study chair
Zhongshan Hospital, Fudan University, Shanghai, China
Stavros N Stavropoulos, MD study director
NYU Winthrop Hospital, Mineola, NY, USA
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Submucosal tunneling endoscopic septum division in people with Zenker Diverticulum, run by Shanghai Zhongshan Hospital at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Quan-Lin Li, MD (+86-021-64041990, liquanlin321@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term change of symptom score (time frame: 1 months after STESD). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03125733, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.