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1.
Trials ; 24(1): 363, 2023 May 30.
Artigo em Inglês | MEDLINE | ID: mdl-37254179

RESUMO

BACKGROUND: Pancreatic ductal carcinoma (PDAC) is the fourth most frequent cause of cancer-related death in the Western world, and its incidence is rising. In patients that undergo curative resection, local recurrence (LR) is frequent. A recently described surgical technique of extended pancreatoduodenectomy (PD) termed the TRIANGLE operation has been proposed as a promising approach to reduce LR and improve disease-free survival in PDAC patients. METHODS: The TRIANGLE trial is a multicentre confirmatory randomised controlled superiority trial with two parallel study groups. A total of 270 patients with suspected or histologically confirmed pancreatic head cancer scheduled for PD will be included in the trial and randomly assigned to the intervention group (extended PD defined as Inoue level 3 dissection along the superior mesenteric and celiac artery as well as removal of all soft tissue in the so-called triangle between the celiac artery, the SMA and the mesenterico-portal axis) or the control group (conventional PD with lymphadenectomy and removal of soft tissue according to current guidelines). The primary endpoint of the trial will be the disease-free survival of patients. Other perioperative outcomes as well as oncological parameters and patient-reported outcomes will be analysed as secondary outcomes. DISCUSSION: Despite multimodal treatment, LR remains high and disease-free survival is limited following PD for PDAC. The TRIANGLE operation could address these shortcomings of conventional PD as indicated in several retrospective studies. However, this technique could be associated with more adverse events for patients including intractable diarrhoea. The TRIANGLE trial will close the evidence gap as well as offer a risk-benefit assessment of this more radical approach to PD. TRIAL REGISTRATION: German Clinical Trials Register DRKS00030576 (UTN U1111-1243-4412) 19th December 2022.


Assuntos
Carcinoma Ductal Pancreático , Neoplasias de Cabeça e Pescoço , Neoplasias Pancreáticas , Humanos , Pancreaticoduodenectomia/efeitos adversos , Pancreaticoduodenectomia/métodos , Estudos Retrospectivos , Pâncreas/cirurgia , Carcinoma Ductal Pancreático/cirurgia , Neoplasias de Cabeça e Pescoço/cirurgia , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como Assunto , Neoplasias Pancreáticas
2.
Z Gastroenterol ; 59(3): 214-224, 2021 Mar.
Artigo em Alemão | MEDLINE | ID: mdl-33506450

RESUMO

BACKGROUND: The support group "Arbeitskreis der Pankreatektomierten e. V. (AdP)" was founded in 1976 and is the largest group of individuals affected by pancreatic disease in Germany. Members of the AdP support patients with pancreatic disease. This patient-initiated, cross-sectional study intends to present the results of pancreatic surgery from the perspective of patients. METHODS: Since March the 3 rd, 2018, members of the AdP received a questionnaire with eleven categories of questions concerning their medical history. This data was gathered in a medical database and analysed. RESULTS: 625 members were operated upon, with 57.5 % receiving pancreaticoduodenectomy, 15.5 % distal pancreatectomy, 23.2 % total pancreatectomy, and 4.0 % another or unknown operation. 37.9 % were diagnosed with pancreatic cancer, 38.2 % with another type of pancreatic tumour, 25 % with pancreatitis, 4 % with autoimmune pancreatitis and 2.7 % with other rare entities.82 patients of 237 pancreatic cancer patients survived more than 5 years. 24.5 % of the 237 patients reported have a second primary malignancy and 13.9 % have close family members with pancreatic cancer.Weight loss after pancreatic surgery was dependant on the type of operation with the greatest after pancreatectomy (17.8 ±â€Š9.5 kg). The prevalence of diabetes was 54.1 %, the incidence of new onset perioperative diabetes 33.3 %. 91.5 % needed pancreatic enzyme replacement therapy, on average 189 417 IE/day. The reported quality of life was independent from type of surgery received. CONCLUSION: Following complex pancreatic surgery, patients are confronted with daily lifelong challenges. AdP members offering their shared experiences offer meaningful support to newly affected patients. Individuals affected by pancreatic disease could be an important but underutilised resource to studying these diseases.


Assuntos
Pancreatectomia/métodos , Neoplasias Pancreáticas/cirurgia , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/psicologia , Qualidade de Vida/psicologia , Idoso , Estudos Transversais , Diabetes Mellitus Tipo 2/epidemiologia , Feminino , Alemanha/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias Pancreáticas/epidemiologia , Neoplasias Pancreáticas/mortalidade , Pancreaticoduodenectomia , Complicações Pós-Operatórias/mortalidade , Prevalência , Grupos de Autoajuda , Inquéritos e Questionários
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