Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-02-01 @ 6:38 AM
Study NCT ID:
NCT02448966
Status:
UNKNOWN
Last Update Posted:
2015-05-20
First Post:
2015-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Traditional Three-incision Esophagectomy Versus Minimally Invasive Thorascopic and Laparoscopic Esophagectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-19', 'studyFirstSubmitDate': '2015-05-08', 'studyFirstSubmitQcDate': '2015-05-19', 'lastUpdatePostDateStruct': {'date': '2015-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long term survival', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Disease free survival', 'timeFrame': '5 years'}, {'measure': 'Postoperative complications', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Esophageal Cancer']}, 'descriptionModule': {'briefSummary': 'Esophageal carcinoma is an aggressive malignancy with poor prognosis. Surgical resection remains the most effective method for this malignant disease. VATS esophagectomy has become more and more popular in China and around the world. Although VATS esophagectomy has been proven to be effective in preventing respiratory complications, there is still no ample evidences to demonstrate that VATS esophagectomy is as effective as traditional three-incision esophagectomy in lymph node dissection and is equal or superior in long-term survival. The purpose of this large scale prospective observational study is to compare the minimally invasive thorascopic/laparoscopic esophagectomy with traditional three-incision esophagectomy in lymph node dissection, postoperative recovery, postoperative complications, and long-term survival.', 'detailedDescription': 'Esophageal carcinoma is an aggressive malignancy with poor prognosis,For these patients, radical esophagectomy is the cornerstone of multimodality treatment with curative intent. Transthoracic esophagectomy is the preferred surgical approach worldwide allowing for en-bloc resection of the tumor. However, the percentage of cardiopulmonary complications associated with the traditional three-incision esophagectomy is high.Recent studies have shown that the minimally invasive thorascopic and laparoscopic esophagectomy is at least equivalent to the open transthoracic approach for esophageal cancer in terms of short-term oncological outcomes,including reduced blood loss, shorter ICU stay,and lower pulmonary complication rate, but the evidence is not ample because the sample size is not enough.The objective of this study is to compare the efficacy, perioperative complications, lymph node dissection and long term survival between the thoracic esophageal cancer patients treated by minimally invasive thorascopic/laparoscopic esophagectomy and open transthoracic esophagectomy by three incisions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'cT1b-3N0-1M0 thoracic esophageal cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with histologically proven squamous cell esophageal cancer, without any previous anti-tumor therapy;\n2. Preoperative clinical TNM stage:cT1b-3N0-1M0;\n3. Adequate cardiopulmonary, liver, brain and kidney function which can tolerate the esophagectomy either via traditional tree-incision or minimally invasive thorascopic/laparoscopic esophagectomy;\n4. Preoperative assessment by CT and EUS is fit for minimally invasive thorascopic/laparoscopic esophagectomy;\n5. Willing to participate the clinical trial and sign the informed consent before being enrolled into clinical trail.\n\nExclusion Criteria:\n\n1. Previous use of anti-cancer therapy;\n2. Preoperative clinical TNM stage: N2-3 or M1;\n3. Inadequate cardiopulmonary,liver, brain and kidney function for surgery;\n4. Previous malignancy history;\n5. Unwilling to participate the clinical trial and refuse to sign informed consent.'}, 'identificationModule': {'nctId': 'NCT02448966', 'briefTitle': 'Traditional Three-incision Esophagectomy Versus Minimally Invasive Thorascopic and Laparoscopic Esophagectomy', 'organization': {'class': 'UNKNOWN', 'fullName': 'ChineseAMS'}, 'officialTitle': 'Traditional Three-incision Esophagectomy Versus Minimally Invasive Thorascopic/Laparoscopic Esophagectomy for cT1b-3N0-1M0 Thoracic Esophageal Cancer', 'orgStudyIdInfo': {'id': 'NKTRDP-2015BAI12B08-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Traditional open esophagectomy', 'description': 'Treated by traditional three-incision esophagectomy in the centers with enough experience in esophagectomy via right thoracotomy and the volume ≧50 cases each year.', 'interventionNames': ['Procedure: open esophagectomy']}, {'label': 'Minimally invasive eophagectomy', 'description': 'treated by minimally invasive thorascopic/laparoscopic esophagectomy in the centers with enough experience in VATS esophagectomy and the volume≧50 cases each year.', 'interventionNames': ['Procedure: Minimally invasive esophagectomy']}], 'interventions': [{'name': 'open esophagectomy', 'type': 'PROCEDURE', 'armGroupLabels': ['Traditional open esophagectomy']}, {'name': 'Minimally invasive esophagectomy', 'type': 'PROCEDURE', 'armGroupLabels': ['Minimally invasive eophagectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yousheng Mao, MD', 'role': 'CONTACT', 'email': 'maoysherx@126.com', 'phone': '8610-87787138'}, {'name': 'Zhirong Zhang, MD', 'role': 'CONTACT', 'email': 'zhangzr@cicams.ac.cn', 'phone': '8610-87788798'}, {'name': 'Jie He, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cancer hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yousheng Mao, MD', 'role': 'CONTACT', 'email': 'maoysherx@126.com', 'phone': '8610-87787138'}, {'name': 'Zhirong Zhang, MD', 'role': 'CONTACT', 'email': 'zhangzr@cicams.ac.cn', 'phone': '8610-87788798'}], 'overallOfficials': [{'name': 'Jie He, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking University Cancer Hospital & Institute', 'class': 'OTHER'}, {'name': 'Henan Cancer Hospital', 'class': 'OTHER_GOV'}, {'name': 'Hebei Medical University Fourth Hospital', 'class': 'OTHER'}, {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, {'name': 'Harbin Medical University', 'class': 'OTHER'}, {'name': 'Sichuan Cancer Hospital and Research Institute', 'class': 'OTHER'}, {'name': 'Fujian Cancer Hospital', 'class': 'OTHER_GOV'}, {'name': 'Liaoning Cancer Hospital & Institute', 'class': 'OTHER'}, {'name': 'Hunan Cancer Hospital', 'class': 'OTHER'}, {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, {'name': 'Zhejiang Cancer Hospital', 'class': 'OTHER'}, {'name': 'Tang-Du Hospital', 'class': 'OTHER'}, {'name': 'Shanghai Chest Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'President', 'investigatorFullName': 'Jie He', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences'}}}}