Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2026-03-18 @ 1:57 AM
Study NCT ID:
NCT04100304
Status:
UNKNOWN
Last Update Posted:
2019-09-24
First Post:
2019-09-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Evaluation of the Remaining Part of the Liver for Liver Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069916', 'term': 'Endoscopic Mucosal Resection'}], 'ancestors': [{'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2022-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-20', 'studyFirstSubmitDate': '2019-09-17', 'studyFirstSubmitQcDate': '2019-09-20', 'lastUpdatePostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation', 'timeFrame': 'preoperative', 'description': 'Evaluation of the remaining part of the liver by CTvolumetry for further management as liver transplant'}], 'secondaryOutcomes': [{'measure': 'energy expenditure', 'timeFrame': '[ Time Frame: 30 days ]', 'description': 'Change in total energy expenditure (Kcal) following liver resection'}, {'measure': 'Procedural parameters', 'timeFrame': 'intraoperative', 'description': 'including intraoperative blood loss'}, {'measure': 'Long-term outcomes', 'timeFrame': '5 years', 'description': '5-year tumor recurrence rate'}, {'measure': 'Perioperative liver function', 'timeFrame': '30 days preoperative', 'description': 'including serum levels of alanine aminotransferase (ALT)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Diseases']}, 'referencesModule': {'references': [{'pmid': '31521373', 'type': 'BACKGROUND', 'citation': 'Wang Z, Sun H, Li K, Yao W, Dong K, Ma Y, Zheng S. Prognostic factor analysis of stage 4S neuroblastoma in infant patients: A single center study. J Pediatr Surg. 2019 Dec;54(12):2585-2588. doi: 10.1016/j.jpedsurg.2019.08.031. Epub 2019 Aug 30.'}, {'pmid': '31519626', 'type': 'BACKGROUND', 'citation': 'Horiuchi T, Haruki K, Shiba H, Sakamoto T, Saito N, Shirai Y, Iwase R, Fujiwara Y, Yanaga K. Assessment of Outcome of Hepatic Resection for Extremely Elderly Patients With a Hepatic Malignancy. Anticancer Res. 2019 Sep;39(9):5143-5148. doi: 10.21873/anticanres.13709.', 'retractions': [{'pmid': '31704878', 'source': 'Anticancer Res. 2019 Nov;39(11):6418'}]}, {'pmid': '31518491', 'type': 'BACKGROUND', 'citation': 'Rotellar F, Marti-Cruchaga P, Zozaya G, Tuero C, Lujan J, Benito A, Hidalgo F, Lopez-Olaondo L, Pardo F. Standardized laparoscopic central hepatectomy based on hilar caudal view and root approach of the right hepatic vein. J Hepatobiliary Pancreat Sci. 2020 Jan;27(1):E7-E8. doi: 10.1002/jhbp.669. Epub 2019 Oct 10.'}, {'pmid': '31520695', 'type': 'BACKGROUND', 'citation': 'Huiskens J, Bolhuis K, Engelbrecht MR, De Jong KP, Kazemier G, Liem MS, Verhoef C, de Wilt JH, Punt CJ, van Gulik TM; Dutch Colorectal Cancer Group. Outcomes of Resectability Assessment of the Dutch Colorectal Cancer Group Liver Metastases Expert Panel. J Am Coll Surg. 2019 Dec;229(6):523-532.e2. doi: 10.1016/j.jamcollsurg.2019.08.1445. Epub 2019 Sep 11.'}]}, 'descriptionModule': {'briefSummary': '* Review the outcomes of the current treatments modalities.\n* Give an effective treatment .\n* Improve the outcome of these patients and decease rate of recurrence and complications.\n* An adequate future liver remnant (FLR) reduces the risk of postoperative liver failure after major hepatectomy.\n* incurs a risk of postoperative liver dysfunction and infection and there is a lack of objective evidence relating residual liver volume to these complications', 'detailedDescription': 'A liver resection is the surgical removal of all or a portion of the liver. It is also referred to as a hepatectomy, full or partial. A complete liver resection is performed in the setting of a transplant a diseased liver is removed from a deceased donor (cadaver). A living donor may also provide a piece of liver tissue which is procured through a partial hepatectomy, The procedure may be performed through a traditional open procedure or using minimally invasive techniques.\n\nWhen is Liver Resection Performed Most hepatectomies are performed for the treatment of hepatic neoplasms, both benign or malignant. Benign neoplasms include hepatocellular adenoma, hepatic hemangioma and focal nodular hyperplasia.The most common malignant neoplasms (cancers) of the liver are metastases; those arising from colorectal cancer are among the most common, and the most amenable to surgical resection. The most common primary malignant tumour of the liver is the hepatocellular carcinoma. Hepatectomy may also be the procedure of choice to treat intrahepatic gallstones or parasitic cysts of the liver.\n\nLiver surgery is safe when performed by experienced surgeons with appropriate technological and institutional support. As with most major surgical procedures, there is a marked tendency towards optimal results at the hands of surgeons with high caseloads in selected centres (typically cancer academic medical centers and transplantation centers).\n\nPartial hepatectomy is surgery to remove part of the liver. Only people with good liver function who are healthy enough for surgery and who have a single tumor that has not grown into blood vessels can have this operation.\n\nImaging tests, such as CT or MRI with angiography are done first to see if the cancer can be removed completely. Still, sometimes during surgery the cancer is found to be too large or has spread too far to be removed, and the surgery that has been planned cannot be done.\n\nCan a portion of the remaining normal liver grow back? When a portion of a normal liver is removed, the remaining liver can grow back (regenerate) to the original size within several weeks. A cirrhotic liver, however, cannot grow back. Therefore, before resection is performed for HCC, the non-tumor portion of the liver should be biopsied to determine whether there is associated cirrhosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing liver resection for benign or malignant hepatic neoplasm at the time of study(two years)\n* Patient consent.\n* Age of the patient : Any age\n\nExclusion Criteria:\n\n* patients has contraindication to do liver resection surgery.\n* patients who are unfit for any surgical interventions.\n* patients who refuse the operation or refusing to share his data.'}, 'identificationModule': {'nctId': 'NCT04100304', 'briefTitle': 'Preoperative Evaluation of the Remaining Part of the Liver for Liver Resection', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Preoperative Evaluation of the Remaining Part of the Liver for Liver Resection', 'orgStudyIdInfo': {'id': 'liver resection'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'patient under going liver resection', 'interventionNames': ['Diagnostic Test: resection']}], 'interventions': [{'name': 'resection', 'type': 'DIAGNOSTIC_TEST', 'description': 'CT volumetry,liver function,biopsy before resection', 'armGroupLabels': ['patient under going liver resection']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Moaz Ahmed, master', 'role': 'CONTACT', 'email': 'moathahmad294@gmail.com', 'phone': '01097179297'}, {'name': 'Salah Ibrahim, professor', 'role': 'CONTACT', 'email': 'salah.ibrahim@med.au.edu.eg', 'phone': '01061616104'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor at general surgery department', 'investigatorFullName': 'Moaz Ahmed Sayed Ahmed', 'investigatorAffiliation': 'Assiut University'}}}}