Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT03525067
Status:
COMPLETED
Last Update Posted:
2018-05-15
First Post:
2018-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Colonization of Bile Ducts and Postoperative Infectious Complications of Pancreaticoduodenectomies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D001650', 'term': 'Bile Duct Neoplasms'}, {'id': 'D004379', 'term': 'Duodenal Neoplasms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D001658', 'term': 'Biliary Fistula'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D018589', 'term': 'Gastroparesis'}], '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': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-14', 'studyFirstSubmitDate': '2018-04-26', 'studyFirstSubmitQcDate': '2018-05-14', 'lastUpdatePostDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative infectious complications at postoperative day 90', 'timeFrame': 'Postoperative time until day 90', 'description': 'Patients with postoperative infectious complications and compare bacteriological results of samples with bile samples.'}], 'secondaryOutcomes': [{'measure': 'Mortality before ICU discharge', 'timeFrame': '90 days', 'description': 'Mortality rate before ICU discharge'}, {'measure': 'Mortality post operative day 28', 'timeFrame': '28 days', 'description': 'Mortality rate at post operative day 28'}, {'measure': 'Mortality post operative day 90', 'timeFrame': '90 days', 'description': 'Mortality rate at post operative day 90'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatic Cancer', 'Sepsis', 'Bile Duct Cancer', 'Duodenal Cancer', 'Bile Duct; Obliteration', 'Post-Op Complication', 'Post-Op Infection', 'Fistula, Biliary', 'Fistula', 'Delayed Gastric Emptying']}, 'descriptionModule': {'briefSummary': 'The aim of the present prospective study was, first, to verify the correlation between biliary colonization and postoperative infectious complications, and secondarily to asses morbidity and mortality for patients who underwent pancreaticoduodenectomy.\n\nThe hypothesis is that a proportion of post-operative infections after pancreaticoduodenectomy is due to bacteria that colonize the bile ducts during the preoperative period.', 'detailedDescription': 'Pancreaticoduodenectomy is part of the curative treatment of periampullary neoplasms. Postoperative mortality for this procedure is between 1 and 5 %, and morbidity ranging from 30 to 50%. Infectious complications, with pancreatic fistula and gastric delayed empting, are an important part of this morbidity, affecting nearly 35% of patients.\n\nOne of the risk factors of infectious complications is the presence of a preoperative obstructive jaundice, due to obstruction of bile ducts by the tumor. In this case, it is proposed to perform a preoperative drainage of the bile ducts, preferably by endoscopic procedure (ERCP), associated with the placement of a endoprosthesis. However, this procedure is controversial, this one increasing postoperative morbidity, and in particular the rate of infectious complications. One explanation of these events is the bacteriological contamination of the bile ducts during the endoscopic procedure. In addition, it has been observed for the patients who have benefited from preoperative drainage, the biliary flora is predominantly polymicrobial and may contain multiresistant nosocomial germs, unlike patients who have not benefited from this procedure, whose biliary flora is predominantly sterile or monomicrobial. This colonization by multiresistant germs may have consequences in the postoperative period, in fact, up to 49% of the germs found in the bile samples are also found in the samples taken during postoperative infectious events. This microbial release could make it more difficult to take care of postoperative infections, with less efficacy of conventional antibiotic treatments.\n\nThe aim of the present prospective study was, first, to verify the correlation between biliary colonization and postoperative infectious complications, and secondarily to asses morbidity and mortality in patients who underwent pancreaticoduodenectomy. Patients whit colonized bile and patients with sterile bile were compared for these outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients over the age of 18, patients underwent programmed pancreaticoduodenectomy for periampullary neoplasms, involving pancreas head adenocarcinoma, malignant ampulloma and intra papillary and mucinous neoplasm', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients over the age of 18\n* patients underwent programmed pancreaticoduodenectomy\n\nExclusion Criteria:\n\n* Patients underwent emergency pancreaticoduodenectomy (delay less than 48 hours)\n* Patients had not been taken of a biliary sample in intraoperative period'}, 'identificationModule': {'nctId': 'NCT03525067', 'briefTitle': 'Colonization of Bile Ducts and Postoperative Infectious Complications of Pancreaticoduodenectomies', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Colonization of Bile Ducts and Postoperative Infectious Complications of Pancreaticoduodenectomies', 'orgStudyIdInfo': {'id': 'PSS2016/PERTEK/ELR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Bile Samples', 'description': 'Patients underwent pancreaticoduodenectomy who had intraoperative bile sampling for bacterial examination.', 'interventionNames': ['Other: Bile sampling for bacterial examination']}], 'interventions': [{'name': 'Bile sampling for bacterial examination', 'type': 'OTHER', 'description': 'At the beginning of pancreaticoduodenectomy, patients had bile sampling from the gallbladder or from the common bile duct for bacterial examination and study of susceptibility to antibiotics.', 'armGroupLabels': ['Patients with Bile Samples']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54035', 'city': 'Nancy', 'state': 'Grand Est', 'country': 'France', 'facility': 'CHRU Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'overallOfficials': [{'name': 'Jean Pierre Pertek, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHRU Nancy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}