Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-01-08 @ 8:54 PM
Study NCT ID:
NCT03125733
Status:
UNKNOWN
Last Update Posted:
2018-08-03
First Post:
2017-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A New Treatment for Zenker's Diverticulum-submucosal Tunneling Endoscopic Septum Division
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016672', 'term': 'Zenker Diverticulum'}], 'ancestors': [{'id': 'D004936', 'term': 'Diverticulum, Esophageal'}, {'id': 'D004240', 'term': 'Diverticulum'}, {'id': 'D000076385', 'term': 'Diverticular Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-06-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-02', 'studyFirstSubmitDate': '2017-04-16', 'studyFirstSubmitQcDate': '2017-04-19', 'lastUpdatePostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in quality of life score', 'timeFrame': 'Baseline and 12 months after STESD', 'description': "Patients' quality of life is recorded by using the SF-36 system"}], 'primaryOutcomes': [{'measure': 'Short-term change of symptom score', 'timeFrame': '1 months after STESD', 'description': "Symptoms for Zenker's diverticulum are scored at follow-up visits and compared with pre-STESD value"}, {'measure': 'Peri-operative adverse events', 'timeFrame': 'start of STESD to 30 days post-op', 'description': 'Details and grading for any adverse event as defined by the ASGE lexicon are recorded during the peri-operative period'}], 'secondaryOutcomes': [{'measure': 'Mid-term change of symptom score', 'timeFrame': '12 months after STESD', 'description': "Symptoms for Zenker's diverticulum are evaluated at follow-up visit and compared to pre-STESD value"}, {'measure': 'Change of diverticulum size under EGD', 'timeFrame': '1 months after STESD', 'description': 'ESD is done at follow-up visit and configuration of the diverticulum is compared to that pre-STESD'}, {'measure': 'Change of diverticulum size under esophagram', 'timeFrame': '1 months after STESD', 'description': 'Barium esophagram is done at follow-up visit and configuration of the diverticulum is compared to that pre-STESD'}, {'measure': 'Call for other treatments, such as repeat myotomy', 'timeFrame': '12 months after STESD', 'description': "Call for any additional treatment for Zenker's diverticulum is recorded at follow-up visits"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endoscopy, Digestive system', 'Natural orifice transluminal endoscopic surgery', 'Therapeutic', 'Complications'], 'conditions': ['Zenker Diverticulum']}, 'referencesModule': {'references': [{'pmid': '26344886', 'type': 'BACKGROUND', 'citation': "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': '18401278', 'type': 'BACKGROUND', 'citation': "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': '20189503', 'type': 'BACKGROUND', 'citation': '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': '12440629', 'type': 'BACKGROUND', 'citation': "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': '18197932', 'type': 'BACKGROUND', 'citation': "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': '24055983', 'type': 'BACKGROUND', 'citation': "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': '27664512', 'type': 'BACKGROUND', 'citation': "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': '25249144', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nTraditional 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.\n\nA 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.\n\nThe 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.", 'detailedDescription': "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.\n\nAdverse events are recorded and graded according to the system suggested by the ASGE workshop (Cotton, GIE, 2010)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of Zenker's diverticulum by symptoms, esophagram and/ or EGD\n* Symptomatic score≥2 in any of the symptoms or ≥3 in total\n* Patients or legal surrogates willing and competent to give informed consent and to comply with follow up visits and tests\n\nExclusion Criteria:\n\n* Patients with minimal symptoms (score ≤1 in all four symptoms and \\<3 in total)\n* Presence of coagulopathy or pregnancy\n* 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"}, 'identificationModule': {'nctId': 'NCT03125733', 'acronym': 'STESD', 'briefTitle': "A New Treatment for Zenker's Diverticulum-submucosal Tunneling Endoscopic Septum Division", 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': "A Prospective International Multicenter Study on the Efficacy and Safety of Submucosal Tunneling Endoscopic Septum Division (STESD) for the Treatment of Zenker's Diverticulum", 'orgStudyIdInfo': {'id': 'STESD for Zenker'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'STESD', 'description': 'Submucosal tunneling endoscopic septum division', 'interventionNames': ['Procedure: Submucosal tunneling endoscopic septum division']}], 'interventions': [{'name': 'Submucosal tunneling endoscopic septum division', 'type': 'PROCEDURE', 'description': 'STESD includes 4 steps:\n\n1. 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.\n2. 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.\n3. Septum Division: cricopharyngeal myotomy is performed longitudinally along the mid-line of the septum and ends in the normal esophageal muscle.\n4. Mucosal Closure: the mucosa incision, as well as any accidental mucosotomy if present, is closed with hemostatic clips.', 'armGroupLabels': ['STESD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11501', 'city': 'Mineola', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maria Kollarus, RN', 'role': 'CONTACT', 'email': 'maria.kollarus@nyulangone.org', 'phone': '516-663-4652'}, {'name': 'Wilmide Maignan', 'role': 'CONTACT', 'email': 'WMaignan@nyuwinthrop.org', 'phone': '+1(516)663-4623'}, {'name': 'Stavros N Stavropoulos, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rani Modayil, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'NYU Winthrop Hospital', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Quan-Lin Li, MD', 'role': 'CONTACT', 'email': 'liquanlin321@126.com', 'phone': '+85-021-64041990'}, {'name': 'Ping-Hong Zhou, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Quan-Lin Li, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Quan-Lin Li, MD', 'role': 'CONTACT', 'email': 'liquanlin321@126.com', 'phone': '+86-021-64041990'}, {'name': 'Xiao-Cen Zhang, MD', 'role': 'CONTACT', 'email': 'xcezhang@gmail.com', 'phone': '+86-15000448731'}], 'overallOfficials': [{'name': 'Ping-Hong Zhou, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Zhongshan Hospital, Fudan University, Shanghai, China'}, {'name': 'Stavros N Stavropoulos, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NYU Winthrop Hospital, Mineola, NY, USA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Winthrop University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}