Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-01-06 @ 9:27 PM
Study NCT ID:
NCT03984734
Status:
COMPLETED
Last Update Posted:
2019-06-13
First Post:
2019-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life and Nutritional Status After Two Surgical Techniques in Pancreatoduodenectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018589', 'term': 'Gastroparesis'}], 'ancestors': [{'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016577', 'term': 'Pancreaticoduodenectomy'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-11', 'studyFirstSubmitDate': '2019-03-25', 'studyFirstSubmitQcDate': '2019-06-11', 'lastUpdatePostDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of DGE', 'timeFrame': 'within the first 90 days after surgery', 'description': 'Nasogastric tube not removed before the 10th postoperative days or if liquids were not tolerated before the 14th postoperative day'}], 'secondaryOutcomes': [{'measure': 'Postoperative morbidity', 'timeFrame': 'within the first 90 days after surgery', 'description': 'Appearance of any complication during the hospital stay'}, {'measure': 'Postoperative mortality', 'timeFrame': 'within the first 90 days after surgery', 'description': 'Any death that happens during the hospital admission or within 90 days after surgery'}, {'measure': 'Length of hospital stay', 'timeFrame': 'within the first 90 days after surgery', 'description': 'Postoperative hospital stay after pancreatoduodenectomy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Delayed Gastric Emptying', 'Pylorus-preserving pancreatoduodenectomy'], 'conditions': ['Delayed Gastric Emptying']}, 'referencesModule': {'references': [{'pmid': '35786739', 'type': 'DERIVED', 'citation': 'Busquets J, Martin S, Secanella L, Sorribas M, Cornella N, Altet J, Pelaez N, Bajen M, Carnaval T, Videla S, Fabregat J. Delayed gastric emptying after classical Whipple or pylorus-preserving pancreatoduodenectomy: a randomized clinical trial (QUANUPAD). Langenbecks Arch Surg. 2022 Sep;407(6):2247-2258. doi: 10.1007/s00423-022-02583-9. Epub 2022 Jul 4.'}]}, 'descriptionModule': {'briefSummary': 'This was a randomized unblinded single-centre trial. The main hypothesis of the study was that pylorus-preserving pancreatoduodenectomy reduces the incidence of delayed gastric emptying . Patients undergoing pancreatoduodenectomy were randomized to undergo one of two types of surgical technique: pylorus-preserving pancreatoduodenectomy versus stardard pancreatoduodenectomy with antrectomy. The primary endpoint was the incidence and severity of delayed gastric emptying. Secondary endpoints were postoperative morbidity and mortality, length of hospital stay, and nutritional status and quality of life.', 'detailedDescription': 'This was a randomized unblinded single-centre trial without masked evaluation of the main outcome.The authors decided to compare pancreatoduodenectomy with antrectomy versus pancreatoduodenectomy with pyloric preservation. The primary aim of this randomized clinical trial was to determine whether pancreatoduodenectomy with pyloric preservation is associated with a lower incidence and severity of delayed gastric emptying. Secondary endpoints were postoperative complications, postoperative mortality and duration of hospital stay. Patients undergoing pancreatoduodenectomy were randomized to undergo one of two types of gastroenteric anastomosis for reconstruction. Analytical parameters such as C-reactive protein, prealbumin, and albumin; as well as anthropometric measures (mean) as preoperative arm circumference mean and tricipital skinfold mean were registered preoperatively, at 5th week, and at 6th mounth. Scintigraphic study had performed following a specific protocol for gastric emptying. At the end, quality of life was also analized with a quality of life questionnaire (QLPAN26) preoperativelly and postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who underwent surgical resection of the head of the pancreas at the authors' institution from August 2003 to August 2008. Adults of either sex aged over 18 years were included.\n\nExclusion Criteria:\n\n* Associated resections of other organs, except for the portal or superior mesenteric vein\n* Total pancreatectomy\n* Previous gastrectomy or other gastric surgeries\n* Neoadjuvant treatment\n* Liver cirrhosis."}, 'identificationModule': {'nctId': 'NCT03984734', 'acronym': 'QUANUPAD', 'briefTitle': 'Quality of Life and Nutritional Status After Two Surgical Techniques in Pancreatoduodenectomy', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitari de Bellvitge'}, 'officialTitle': 'Randomized Trial Comparing Quality of Life and Nutritional Status Between Pylorus-preserving Pancreatoduodenectomy Versus Standard Pancreatoduodenectomy (QUANUPAD TRIAL)', 'orgStudyIdInfo': {'id': 'QUANUPAD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Patients undergoing pancreatoduodenectomy with antrectomy', 'interventionNames': ['Procedure: Pancreatoduodenectomy with antrectomy']}, {'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'Patients undergoing pancreatoduodenectomy with pylorus-preserving pancreatoduodenectomy', 'interventionNames': ['Procedure: Pylorus-preserving pancreatoduodenectomy']}], 'interventions': [{'name': 'Pancreatoduodenectomy with antrectomy', 'type': 'PROCEDURE', 'armGroupLabels': ['Control group']}, {'name': 'Pylorus-preserving pancreatoduodenectomy', 'type': 'PROCEDURE', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Juan Fabregat Prous, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitari de Bellvitge'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitari de Bellvitge', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff surgeon Bellvitge Universitary Hospital', 'investigatorFullName': 'BUSQUETS, JULI', 'investigatorAffiliation': 'Hospital Universitari de Bellvitge'}}}}