Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2026-01-01 @ 7:23 AM
Study NCT ID:
NCT07087392
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-28
First Post:
2025-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inverted-Ω Anastomosis in Laparoscopic Duodenum-Preserving Pancreatic Head Resection or Laparoscopic Central Pancreatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-07-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2025-07-08', 'studyFirstSubmitQcDate': '2025-07-24', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and assessment of the surgical process', 'timeFrame': 'During operation', 'description': 'The incidence of intraoperative adverse events such as conversion to open surgery rate'}, {'measure': 'Operative time', 'timeFrame': 'During operation', 'description': 'Operative time'}, {'measure': 'Intraoperative blood loss', 'timeFrame': 'During operation', 'description': 'Intraoperative blood loss'}, {'measure': 'Postoperative complications', 'timeFrame': 'From the date of surgery (Day 0) up to 90 days postoperatively', 'description': 'The incidence and severity of postoperative complications, as defined by the International Study Group on Pancreatic Surgery (ISGPS)'}], 'secondaryOutcomes': [{'measure': 'Short-term survival', 'timeFrame': 'From the date of surgery (Day 0) up to 3 years postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatic Cystic Neoplasms']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if inverted-Ω anastomosis after pancreatic head resection or mid-pancreatectomy works in benign or low-grade malignant tumor. It will also learn about the safety and feasibility of inverted-Ω anastomosis. The main questions it aims to answer are:\n\n1. Does inverted-Ω anastomosis operate safely? (operative time, blood loss, transfusion and conversion rate)\n2. What is the incidence and severity of postoperative complications in inverted -Ω anastomosis? What advantages does it have over conventional anastomosis methods such as roux-en-y？'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 18 to 75 years old, gender not limited;\n2. Patients diagnosed with benign or low-grade malignant tumors in the head or middle section of the pancreas by CT or MRI;\n3. ECOG score 0-1.\n\nExclusion Criteria:\n\n1. Those with severe heart, liver or kidney insufficiency, or those who are assessed as intolerant to surgery or anesthesia, or those with ASA grade \\> 3;\n2. Patients with a history of or concurrent other malignant tumors, or other serious infections or infectious diseases, or those who are unable to complete the anastomosis surgery;\n3. Uncontrollable concomitant diseases, including but not limited to severe coronary artery disease, COPD or asthma, uncontrollable cerebrovascular diseases, symptomatic congestive failure, unstable angina pectoris, arrhythmia, or other diseases that the researchers consider ineligible for enrollment;\n4. Patients who have undergone other upper abdominal surgeries and digestive tract reconstruction procedures in the past;\n5. Patients requiring combined organ resection;\n6. Preoperative assessment suggested that the patient might have factors such as active ulcers and bleeding in the digestive tract;\n7. Pregnant and lactating women;\n8. Any uncertain factors that have an impact on the patient's safety or compliance."}, 'identificationModule': {'nctId': 'NCT07087392', 'briefTitle': 'Inverted-Ω Anastomosis in Laparoscopic Duodenum-Preserving Pancreatic Head Resection or Laparoscopic Central Pancreatectomy', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'Modified Digestive Tract Reconstruction in Laparoscopic Duodenum-Preserving Pancreatic Head Resection or Laparoscopic Central Pancreatectomy: Inverted-Ω Anastomosis', 'orgStudyIdInfo': {'id': '2025-550'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inverted-Ω Anastomosis', 'description': 'After meeting the inclusion and exclusion criteria, duodenum-preserving pancreatic head resection or mid-pancreatic resection will be performed, and inverted-Ω anastomosis will be carried out during the operation for the reconstruction of the digestive tract', 'interventionNames': ['Procedure: Inverted-Ω Anastomosis']}], 'interventions': [{'name': 'Inverted-Ω Anastomosis', 'type': 'PROCEDURE', 'description': 'After meeting the inclusion and exclusion criteria, duodenum-preserving pancreatic head resection or mid-pancreatic resection will be performed, and inverted-Ω anastomosis will be carried out during the operation for the reconstruction of the digestive tract', 'armGroupLabels': ['Inverted-Ω Anastomosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'contacts': [{'name': 'Zhong Wu', 'role': 'CONTACT', 'email': 'wuzhong0057@163.com', 'phone': '+86 189 8060 6518'}], 'facility': 'West China Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Zhong Wu', 'role': 'CONTACT', 'email': 'wuzhong0057@163.com', 'phone': '+86 189 8060 6518'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Xingchen Peng', 'investigatorAffiliation': 'West China Hospital'}}}}