Clinical Trials: A Practical Approach

Portal hypertension is a major complication of chronic liver disease. Its main clinical consequence, bleeding from ruptured esophagogastric varices, represents a dramatic medical emergency, with mortality rate ranging from 30% to 50%, and is one of the leading causes of death in patients with cirrhosis.

https://aasldpubs.onlinelibrary.wiley.com/doi/pdf/10.1002/hep.1840220145

The treatment of portal hypertension: A meta-analytic review

https://www.journal-of-hepatology.eu/article/S0168-8278(02)00420-8/pdf

Incidence and natural history of small esophageal varices in cirrhotic patients.

Summary
Background

Morphological, haemodynamic and clinical stages of cirrhosis have been proposed, although no definite staging system is yet accepted for clinical practice.



Aim

To investigate whether clinical complications of cirrhosis may define different prognostic disease stages.



Methods

Analysis of the database from a prospective inception cohort of 494 patients. Decompensation was defined by ascites, bleeding, jaundice or encephalopathy. Explored potential prognostic stages: 1, compensated cirrhosis without oesophago-gastric varices; 2, compensated cirrhosis with varices; 3, bleeding without other complications; 4, first nonbleeding decompensation; 5, any second decompensating event. Patient flow across stages was assessed by a competing risks analysis.



Results

Major patient characteristics were: 199 females, 295 males, 404 HCV+, 377 compensated, 117 decompensated cirrhosis. The mean follow-up was 145 ± 109 months without dropouts. Major events: 380 deaths, 326 oesophago-gastric varices, 283 ascites, 158 bleeding, 146 encephalopathy, 113 jaundice, 126 hepatocellular carcinoma and 19 liver transplantation. Patients entering each prognostic stage along the disease course were: 202, stage 1; 216, stage 2; 75 stage 3; 206 stage 4; 213 stage 5. Five-year transition rate towards a different stage, for stages 1–4 was 34.5%, 42%, 65% and 78%, respectively (P < 0.0001); 5-year mortality for stages 1–5 was 1.5%, 10%, 20%, 30% and 88% respectively (P < 0.0001). An exploratory analysis showed that this patient stratification may configure a prognostic system independent of the Child–Pugh score, Model for End Stage Liver Disease and comorbidity.



Conclusion

The development of oesophago-gastric varices and decompensating events in cirrhosis identify five prognostic stages with significantly increasing mortality risks.

https://onlinelibrary.wiley.com/doi/pdf/10.1111/apt.12721

Competing risks and prognostic stages of cirrhosis: A 25-year inception cohort study of 494 patients

The vast majority of pancreatic carcinomas are primary, and, among these, more than 90% are of ductal origin. However, a variety of extrapancreatic tumors may involve the pancreas secondarily and may manifest different clinicopathological characteristics and outcomes. In this study, pathology material from 973 surgical specimens and 4955 adult autopsy cases was reviewed to identify the tumors metastatic to or secondarily involving the pancreas. Biliary and periampullary neoplasms and tumors confined to peripancreatic soft tissue were excluded. In the autopsy series, the pancreas was involved by tumor in 190 cases, and 81 of these were secondary tumors. These were predominantly of epithelial origin, most commonly from lung (34), followed by GI tract (20), kidney (4), breast (3), liver (2), ovary (1), and urinary bladder (1). In addition, there were six tumors of hematopoietic origin, two melanomas, two sarcomas, and two mesotheliomas. Among the 973 surgical specimens, 38 cases contained metastatic tumors to the pancreas. Of these, 11 were lymphomas, and the others were carcinomas of stomach (7), kidney (6), lung (2), liver, prostate, ovary, uterus (1 case of each), and a Merkel cell carcinoma. In addition, there were three malignant gastrointestinal stromal tumors and one retroperitoneal leiomyosarcoma. In conclusion, lung cancer is the most common source of metastasis to pancreas, followed by gastrointestinal carcinomas and lymphomas. These tumors are usually seen in patients with disseminated disease and are detected mainly in autopsies. Secondary tumors constitute about 4% of pancreatic specimens in the authors' surgical database. Approximately one-third of them are clinically mistaken as primary tumors of the pancreas. These are predominantly hematopoietic malignancies or carcinomas of renal or gastric origin. Secondary tumors should be entertained in both the clinical and pathological differential diagnosis of pancreatic neoplasia.

Secondary tumors of the pancreas: an analysis of a surgical and autopsy database and review of the literature

Summary A prospective, controlled study comparing the clinical results of the selective distal splenorenal shunt procedure and the side-to-side portacaval shunt procedure was undertaken in 1980. Ninety-three cirrhotic patients with previous episodes of bleeding from esophageal varices underwent a distal splenorenal shunt procedure (46 patients) or a portacaval shunt procedure (47 patients). The operative mortality rate was 2 percent in both groups. The intraoperative decrease of portal hypertension after the portacaval shunt procedure was higher than after the distal splenorenal shunt procedure (p

Selective distal splenorenal shunt versus side-to-side portacaval shunt. Clinical results of a prospective, controlled study.

Portacaval shunt in the treatment of primary Budd-Chiari syndrome.

The distal splenorenal shunt (DSRS) was compared with the side-to-side portacaval shunt (PCS) in 93 prospectively matched patients with portal hypertension. After 38 months mean follow-up the two shunts had a different incidence of acute encephalopathy (22% in PCS group and 33% in DSRS group) and chronic encephalopathy (35% in PCS group and 17% in DSRS group), but the difference was not statistically significant. However, the only cases of severe and disabling chronic encephalopathy arose after PCS (p = 0.049). Actuarial curves of chronic encephalopathy showed that the maximum rate of encephalopathy (18%) in the DSRS group was reached 27 months after shunt surgery, whereas this value was reached and passed in PCS group only 4 months after shunt. Chronic encephalopathy occurred for a total duration of 20.1 months after PCS and only 11.1 months afer DSRS (p = 0.003) and occupied 46.3% of the follow-p of PCS patients, as contrasted to 18.7% of the follow-up of DSRS patients (p = 0.0001). DSRS is associated with a lower global incidence of chronic HE without severe forms and provides a better quality of life than does a nonselective shunt.

Improved quality of life after distal splenorenal shunt. A prospective comparison with side-to-side portacaval shunt.

The Authors report their experience of 13 cases of metastatic carcinoma of the pancreas, diagnosed over 350 pancreatic cancers examined by digestive angiography (4%). The rarity of this localization is emphasized and is affirmed that any organ may cause pancreatic metastasis (liver, bile ducts, oesofagus) although the kidney and the lung are more frequently the original sites. The pancreatic metastases were of different types but the multilocalized or the total forms don't prevail over the single ones. The angiographic modifications induced by these secondary lesions are evident but not characteristic and diagnosis only of pancreatic tumor can be evocated. Therefore digestive angiography is of high diagnostic value in this cases, although histologic examination is necessary to define the metastatic nature of these lesions.

Diagnosis of secondary tumors of the pancreas. Analysis of 13 cases

This paper analyzes experience with 106 patients treated primarily with DSRS during a ten year period. Operative mortality was 5% of cases. Shunt patency was evaluated by postoperative angiography in 70 patients. A shunt thrombosis and a recanalization of the splenic vein were noted in a patient who had a Britton's operation resulting in a side-to-side shunt. In the other 31 cases, shunt patency was indirectly confirmed by the absence of varices at postoperative or long-term endoscopic examination. At postoperative check, esophageal varices had disappeared in only 19% of patients. However, this rose to 60% at long-term check-up. Ten patients bled from varices in the postoperative period (9%). During the follow-up period, no patient bled from varices, while five patients bled from gastroduodenal lesions (5%). During the postoperative period, 52% of cases had ascites. In the long-term, ascites developed in only 15% of cases and was well controlled by standard medical treatment. Analysis of the actuarial curve showed a 5-year survival rate of 63%. During the follow-up period, 17% of patients experienced at least one episode of acute encephalopathy. Chronic encephalopathy appeared in 14% of cases: ten patients suffered a mild form (10%) and four (4%) a moderate form. No patient had severe chronic encephalopathy. DSRS is effective as treatment of portal hypertension with a low long-term morbidity despite a more troublesome early postoperative period.

The distal splenorenal shunt: an update on experience of 106 cases.

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