Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2025-12-29 @ 5:04 AM
Study NCT ID:
NCT06763250
Status:
RECRUITING
Last Update Posted:
2025-01-08
First Post:
2025-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
In This Study, a Retrospective Analysis Was Conducted to Explore the Risk Factors for Patients Undergoing Pancreaticoduodenal Surgery (PD) to Achieve TO, and a Nomogram Prediction Model Was Further Established to Promote the Standardization and Standardization of PD Surgical Quality Evaluation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D018281', 'term': 'Cholangiocarcinoma'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-02', 'studyFirstSubmitDate': '2025-01-02', 'studyFirstSubmitQcDate': '2025-01-02', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Achieve TO as the main ending', 'timeFrame': 'from January 2016 to August 2024', 'description': 'We expected TO collect 280 PD surgery patients, 262 cases have been collected, of which 158 cases achieved TO as the main outcome, the TO rate is 60.31%.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['textbook outcome', 'pancreatic carcinoma', 'cholangiocarcinoma', 'pancreaticoduodenectomy'], 'conditions': ['Pancreatic Carcinoma', 'Cholangiocarcinoma', 'Pancreaticoduodenectomy']}, 'referencesModule': {'references': [{'pmid': '41128852', 'type': 'DERIVED', 'citation': 'Ma L, Wu S, Cheng Y, Gao Y, Fan J, Zhu C. Laparoscopic duodenum-preserving total pancreatic head resection for benign and low-grade malignant tumors close to the accessory papilla (a case series). Surg Endosc. 2025 Oct 23. doi: 10.1007/s00464-025-12236-9. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'This study is committed TO exploring the risk factors affecting patients receiving pancreaticoduodenal surgery (PD) to achieve TO by retrospective analysis of clinical data of patients receiving PD surgery in Changzhou Second People Hospital from January 2016 to December 2024, and further establishing a nomogram prediction model. In order to promote the standardization and standardization of PD surgical quality assessment.', 'detailedDescription': 'As we all know, pancreaticoduodenectomy (whipple) involving multiple organ reconstruction for pancreatic cancer is known as the \\"surgical ceiling\\", but because of its high postoperative complication rate and poor prognosis, a standardized surgical quality assessment system covering the whole perioperative period is urgently needed. The concept of the textbook ending was born.it first appeared in a 2013 study by Kolfschoten et al for colorectal cancer, in which textbook outcomes were evaluated in an all or none ,manner against six independent expected outcome measures: There were no deaths in hospital or within 30 days after surgery, radical resection, no re-intervention, no stomy, no serious postoperative complications, and no prolonged hospital stay. That is, when patients meet the above six indicators at the same time, they are defined as achieving a textbook outcome .In our study, the textbook outcome is the primary outcome, and the reverse is the secondary outcome.This study is committed TO exploring the risk factors affecting patients receiving pancreaticoduodenal surgery (PD) to achieve TO by retrospective analysis of clinical data of patients receiving PD surgery in Changzhou Second People Hospital from January 2016 to December 2024, and further establishing a nomogram prediction model. In order to promote the standardization and standardization of PD surgical quality assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'From the 260 specimens collected so far in this study, we obtained the description of the study population. In terms of age, 6.53% of the samples were less than 50 years old, 13.84% were more than or equal to 50 years old and 60 years old, 46.54% were more than or equal to 60 years old and 70 years old, 29.23% were more than or equal to 70 years old and 3.86% were more than or equal to 80 years old. In terms of gender, 57.31% of the sample were male and 42.69% were female. All the samples in this study were Han. 98.85% of the sample were married. The population samples for this study were all from the Second People\\'s Hospital of Changzhou City.The risk factors affecting the textbook outcome of PD surgery in this study population were: 1. Diabetes; 2. Preoperative bile duct inflammation; 3. Intraoperative pancreatic duct diameter; 4; Vascular invasion; 5. Duration of operation; 6. Surgical method.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who received radical PD surgery and whose pathological findings were clear tumors;\n2. Complete clinical data preservation.\n\nExclusion Criteria:\n\n1\\. Palliative resection; 2. Tumor metastasis or other primary tumors; 3. Combined with severe organ dysfunction; 4. Postoperative pathology was not clear tumor.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06763250', 'briefTitle': 'In This Study, a Retrospective Analysis Was Conducted to Explore the Risk Factors for Patients Undergoing Pancreaticoduodenal Surgery (PD) to Achieve TO, and a Nomogram Prediction Model Was Further Established to Promote the Standardization and Standardization of PD Surgical Quality Evaluation.', 'organization': {'class': 'OTHER', 'fullName': "Changzhou No.2 People's Hospital"}, 'officialTitle': 'Risk Factors Influencing Textbook Outcomes in PD Surgery-a Single-center Analysis', 'orgStudyIdInfo': {'id': 'CN CZEY'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'We divided the clinical data into a TO group and a non-TO group through retrospective analysis', 'description': 'A textbook outcome (TO) of pancreatic surgery based on an international expert consensus, No postoperative hemorrhage of grade B/C, no postoperative pancreatic fistula of grade B/C, no biliary leakage of grade B/C, Clavien-Dindo complication grade \\< Ⅲ, no death during hospitalization or within 30 days after surgery, and no re-admission within 30 days after discharge were integrated as a comprehensive index. It can reflect the ideal surgical outcome. We divided the clinical data into a TO group and a non-TO group through retrospective analysis. In order to promote the standardization and standardization of PD surgical quality assessment.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '213000', 'city': 'Changzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'zhunfu zhu, PhD', 'role': 'CONTACT', 'email': 'zcfmlm@njmu.edu.cn', 'phone': '13961190702'}], 'facility': "The Second People's Hospital of Changzhou, Jiangsu Province, China", 'geoPoint': {'lat': 31.77359, 'lon': 119.95401}}], 'centralContacts': [{'name': 'Chunfu zhu, MD', 'role': 'CONTACT', 'email': 'zcfmlm@njmu.edu.cn', 'phone': '13961190702'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'luokai zhang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': "Changzhou Second People's Hospital, Jiangsu Province", 'investigatorFullName': 'luokai zhang', 'investigatorAffiliation': "Changzhou No.2 People's Hospital"}}}}