Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-02-21 @ 8:30 AM
Study NCT ID:
NCT03828266
Status:
UNKNOWN
Last Update Posted:
2019-02-04
First Post:
2019-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of Abdominal Complications After GastroEnterological Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057868', 'term': 'Anastomotic Leak'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-31', 'studyFirstSubmitDate': '2019-01-30', 'studyFirstSubmitQcDate': '2019-01-31', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abdominal Infection rate after gastrectomy.', 'timeFrame': 'From surgery until discharge, up to 90 days.', 'description': 'Abdominal Infection includes anastomotic leakage and other intra-abdominal infectious complications.'}, {'measure': 'Abdominal Infection rate after colorectal surgery.', 'timeFrame': 'From surgery until discharge, up to 90 days.', 'description': 'Abdominal Infection includes anastomotic leakage and other intra-abdominal infectious complications.'}], 'secondaryOutcomes': [{'measure': 'Classification of Abdominal Infection after Surgery', 'timeFrame': 'From surgery until discharge, up to 90 days.', 'description': 'Severity classification scored based on Clavien-Dindo score, it includes five different scales indicating different severity of the complication.'}, {'measure': 'Diagnosis time of Abdominal Complication', 'timeFrame': 'From surgery until discharge, up to 90 days.', 'description': '1-3 days after surgery; 4-7 days after surgery; \\>1wk after surgery'}, {'measure': 'Outcome of Abdominal Infection Treatment', 'timeFrame': 'From surgery until discharge, up to 90 days.', 'description': 'Cured before discharge, not cured before discharge, death.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Complication', 'Anastomotic Leak', 'Gastrointestinal Cancer']}, 'referencesModule': {'references': [{'pmid': '40671863', 'type': 'DERIVED', 'citation': 'Wu Z, Gu T, Wang X, Wei T, Shan F, Li Z, Ji J; PACAGE study group. Surgical quality and health utilization of gastric cancer surgery in China: a post hoc analysis of the Prevalence of Abdominal Complications After Gastroenterological Surgery study. BMJ Surg Interv Health Technol. 2025 Jul 15;7(1):e000332. doi: 10.1136/bmjsit-2024-000332. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this multi-centered study is to understand the epidemiology of infectious complications after gastrointestinal surgery in China. In total, 17 centers from China will prospectively register their patients undergo gastric or colorectal surgeries. Patient demographic data, operation information, and postoperative data including the infectious complications and the outcomes will be registered. We expect to include 2000 gastric and 2000 colorectal patients within one year and the study is expected to be finished in 2020.', 'detailedDescription': 'All participating hospital will log in on a website based e-CRF system. Researchers need to register the patient information that three time-points: admission, after surgery, after discharge.\n\nThe detailed registered information includes:\n\nI. Basic and surgical information:\n\nAge, height, weight, history of abdominal surgery, ASA score, surgical procedure, extent of lymph node dissection, extent of resection, time of surgery, amount of bleeding, whether it is emergency surgery, whether it is combined with organ resection, whether it is palliative resection, whether combined with preoperative treatment, whether combined with preoperative infection and intraoperative complications.\n\nII. Postoperative information:\n\nPrimary lesion histological type, margin, pathological stage (pTNM); other complications, postoperative death and discharge time, CRP, PCT, WBC levels.\n\nIII. Abdominal Infection information:\n\nAbdominal infection (Y/N), anastomotic leakage (Y/N), intervention, outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients undergo gastrointestinal (GI) surgery for GI tumor.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planned gastrointestinal surgery.\n* Inform consent received.\n\nExclusion Criteria:\n\n* Endoscopic surgery.\n* Inform consent denied.'}, 'identificationModule': {'nctId': 'NCT03828266', 'acronym': 'PACAGE', 'briefTitle': 'Prediction of Abdominal Complications After GastroEnterological Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'Abdominal Infectious Complications After Gastrointestinal Surgery in China: a Multi-centered Prospective Registry', 'orgStudyIdInfo': {'id': '2018YJZ56'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'Patients will undergo routine clinical practice. There is no additional intervention.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ziyu Li, M.D.', 'role': 'CONTACT', 'email': 'ligregory369@hotmail.com'}, {'name': 'Zhouqiao Wu, M.D.', 'role': 'CONTACT', 'email': 'wuzhouqiao@gmail.com'}, {'name': 'Ziyu Li, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Peking University Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Fuzhou', 'state': 'Fujian', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhaohui Zheng', 'role': 'CONTACT'}], 'facility': 'Fujian Medical University Union Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Xiamen', 'state': 'Fujian', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun You', 'role': 'CONTACT'}], 'facility': 'Xiamen University First Hospital', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yong Li', 'role': 'CONTACT'}], 'facility': "Guangdong People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wu Song', 'role': 'CONTACT', 'email': 'denisewei@126.com'}], 'facility': 'The First Affilliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guanzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiang Yu', 'role': 'CONTACT', 'email': 'balbc@163.com'}], 'facility': 'South Hospital', 'geoPoint': {'lat': 23.06828, 'lon': 113.37117}}, {'city': 'Nanchang', 'state': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhengrong Li', 'role': 'CONTACT'}], 'facility': 'Nanchang University First Hospital', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiaming Zhu', 'role': 'CONTACT'}], 'facility': 'Jilin University Second Hospital', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Dalian', 'state': 'Liaoning', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Pin Liang', 'role': 'CONTACT'}], 'facility': 'Dalian Medical University First Hospital', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': 'Xining', 'state': 'Qinghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Su Yan, MD', 'role': 'CONTACT', 'email': 'yansu3598507@163.com'}], 'facility': 'Qinghai University Affiliated Hospital', 'geoPoint': {'lat': 36.62554, 'lon': 101.75739}}, {'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Changqing Jing', 'role': 'CONTACT'}], 'facility': 'Shandong Provincial Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Qingdao', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhaojian Niu', 'role': 'CONTACT'}], 'facility': 'Qingdao University Affiliated Hospital', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hua Huang', 'role': 'CONTACT'}], 'facility': 'Fudan University Cancer Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hankun Hao', 'role': 'CONTACT'}], 'facility': 'Huashan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lu Zang', 'role': 'CONTACT'}], 'facility': 'Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fenglin Liu', 'role': 'CONTACT'}], 'facility': 'Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Xi’an', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lin Fan', 'role': 'CONTACT'}], 'facility': "Xi'an Jiao Tong University First Hospital", 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jian Zhang', 'role': 'CONTACT'}], 'facility': 'Hangzhou First Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Linghua Zhu', 'role': 'CONTACT'}], 'facility': 'Run Run Shaw Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Zhouqiao Wu, MD PhD', 'role': 'CONTACT', 'email': 'wuzhouqiao@gmail.com', 'phone': '0086-10-88196606'}], 'overallOfficials': [{'name': 'Ziyu Li, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Cancer Hospital & Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Ziyu Li, MD', 'investigatorAffiliation': 'Peking University'}}}}