How to apply clinical cases and medical literature in the framework of a modified “failure mode and effects analysis” as a clinical reasoning tool – an illustration using the human biliary system

BackgroundLiver cancer is the second leading cause of cancer death in men worldwide. Hepatocellular carcinoma usually develops in the setting of cirrhosis or chronic inflammation. Major risk factors for developing hepatocellular carcinoma are chronic hepatitis B or C virus infection, alcoholic cirrhosis, and nonalcoholic fatty liver disease. The most frequent locations for hepatocellular carcinoma to metastasize are the lungs, portal vein, bones, and regional lymph nodes.Case presentationA 41-year-old Sri Lankan man presented with progressive abdominal distension and on examination was found to have a palpable irregular mass in the left lobe of his liver with moderate ascites. His ascitic fluid was an exudate without malignant cells. An ultrasound scan and contrast-enhanced computed tomography of his abdomen showed a large contrast-enhancing lesion in the left lobe of his liver without features of cirrhosis. Laparoscopic assessment revealed peritoneal and omental deposits. Histology of the biopsies taken from the liver lesion, omental deposits, and peritoneal deposits supported a diagnosis of hepatocellular carcinoma. His liver biochemistry was normal and hepatitis serology was negative. He is abstinent from alcohol and did not have metabolic syndrome.ConclusionsIt is rare for a young patient to develop hepatocellular carcinoma with a normal liver without chronic hepatitis B or C infection, or any other risk factors. Intraperitoneal metastasis of non-ruptured hepatocellular carcinoma is also very rare. Here we report a rare case of a 41-year-old man with a large hepatocellular carcinoma in a non-cirrhotic liver without chronic hepatitis who presented with peritoneal and omental metastasis.

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“…“Failure mode and effects analysis” [ 11 ] can be applied as a clinical reasoning tool to our patient. HCC is the potential failure.…”

Section: Discussionmentioning

confidence: 99%

“…HCC is the potential failure. Effects of failure/main clinical features were progressive abdominal distension, discomfort, loss of appetite, and loss of weight [ 11 ]. There was no biochemical or radiological evidence of cirrhosis in our patient.…”

Section: Discussionmentioning

confidence: 99%

Large hepatocellular carcinoma in a non-cirrhotic liver with peritoneal and omental metastasis in a healthy man: a case report

Herath

Kulatunga

2017

J Med Case Reports

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“…This case clearly illustrates the utility of Ishikawa diagrams in delineating possible etiology when presented with gastroenterological and pulmonary symptoms. In our case this was expanded and refined based on other associated symptoms followed by radiological and laboratory examinations [ 16 ].…”

Section: Discussionmentioning

confidence: 99%

Hepato-bronchial fistula secondary to perforated sigmoid diverticulitis: a case report

et al. 2017

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BackgroundPatients with diverticulitis are predisposed to hepatic abscesses via seeding through the portal circulation. Hepatic abscesses are well-documented sequelae of diverticulitis, however instances of progression to hepato-bronchial fistulization are rare. We present a case of diverticulitis associated with hepatic abscess leading to hepato-bronchial fistulization, which represents a novel disease course not yet reported in the literature.Case PresentationA 61-year-old Caucasian man presented with a history of unintentional weight loss and dyspnea both at rest and with exertion. He had a significant tobacco and alcohol misuse history. A massive right-sided pleural effusion was found on chest X-ray, which responded partially to chest tube insertion. A computed tomography scan of his thorax confirmed the presence of innumerable lung abscesses as well as a complex pleural effusion. An indeterminate tiny air pocket at the dome of the liver was also noted. A follow-up computed tomography scan of his abdomen revealed a decompressed hepatic abscess extending into the right pleural space and the right lower lobe. A sigmoid-rectal fistula was also revealed with focal colonic thickening, presumed to be the sequelae of remote or chronic diverticulitis. An interventional radiologist inserted a percutaneous drain into the decompressed hepatic abscess and the instillation of contrast revealed immediate filling of the right pleural space, lung parenchyma, and bronchial tree, confirming a hepato-bronchial fistula. After two concurrent chest tube insertions failed to drain the remaining pleural effusion completely, surgical lung decortication was conducted. Markedly thickened pleura were seen and a significant amount of gelatinous inflammatory material was debrided from the lower thoracic cavity. He recovered well and was discharged 10 days post-thoracotomy on oral antibiotics. The percutaneous liver abscess tube was removed 3 weeks post-discharge from hospital after the drain check revealed that the fistula and abscess had entirely resolved.ConclusionsRefractory right-sided pleural effusion combined with constitutional symptoms should alert clinicians to search for possible hepatic abscess, especially in the context of diverticulitis. The rupture of an untreated hepatic abscess could lead to death from profound sepsis or rarely, as in this case, a hepato-bronchial fistula. Timely investigation and a multidisciplinary treatment approach can lead to improved patient outcomes.

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“…The application areas of the Ishikawa diagram are constantly growing and are employed in a variety of fields. It is something that aids in the drawing of the cause-and-effect diagram for acceptable limits (45).…”

Section: Risk Assessment: Linking Cmas and Cpps To The Drug Product Cqasmentioning

confidence: 99%

Quality by Design (QbD) Paradigm: An Integrated Multivariate Approach to Transdermal Patch System Development

2024

J Rep Pharm Sci

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: The International Council on Harmonization issued quality by design (QbD) guidelines, including Q8 (R2) pharmaceutical development, Q9 quality risk management, and Q10 pharmaceutical quality system, to ensure the quality of pharmaceutical products. For continual and consistent improvement of the quality of pharmaceutical drug products, QbD tools, such as risk assessment, design of experiment, and control strategy, are used, which can solve the narrow areas in product development. Transdermal patch systems (TPS) are gaining attention among scientists and are one of the strong-growing drug delivery systems in the market as a result of numerous benefits, including lowering the dosing frequency, adverse effects and invasiveness, avoiding pre-systemic metabolism, and better patient efficiency and compatibility. Transdermal patch systems are a likable dosage form when compared to other dosage forms. However, several challenges are faced in TPS product development which has hindered enormous products concerning the market status of TPS in comparison to the oral dosage forms. The implementation of the QbD concept was much focused on oral dosage forms. Additionally, the lack of understanding of the development of TPS leads to failure and withdrawal from markets. Therefore, to understand the QbD concepts of TPS, an attempt has been made to review the QbD approach for the development of TPS from the identification of the Quality Target Product Profile to the arrival of design space, which might help the formulator to navigate the sticky areas, in the TPS development.

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How to apply clinical cases and medical literature in the framework of a modified “failure mode and effects analysis” as a clinical reasoning tool – an illustration using the human biliary system

Cited by 6 publications

References 72 publications

Large hepatocellular carcinoma in a non-cirrhotic liver with peritoneal and omental metastasis in a healthy man: a case report

Large hepatocellular carcinoma in a non-cirrhotic liver with peritoneal and omental metastasis in a healthy man: a case report

Hepato-bronchial fistula secondary to perforated sigmoid diverticulitis: a case report

Quality by Design (QbD) Paradigm: An Integrated Multivariate Approach to Transdermal Patch System Development

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