Evaluation of postoperative ascites after somatostatin infusion following hepatectomy for hepatocellular carcinoma by laparotomy: a multicenter randomized double-blind controlled trial (SOMAPROTECT).

BACKGROUND: The majority of patients undergoing hepatectomy for hepatocellular carcinoma (HCC) suffer from underlying liver disease and are exposed to the risk of postoperative ascites, which is favored by an imbalance between portal venous inflow and a diminished hepatic volume. Finding a reversible, non-invasive method for modulating the portal inflow would be of interest as it could be used temporarily during the early postoperative course. Somatostatin, a well-known drug already used in several indications, may limit the risk of postoperative ascites and liver failure by decreasing portal pressure after hepatectomy for HCC in patients with underlying liver disease. We aimed to evaluate the impact of somatostatin postoperative infusion on the incidence of ascites following hepatectomy by laparotomy for HCC in patients with underlying liver disease. METHODS/DESIGN: The SOMAPROTECT study is a multicenter randomized double-blind placebo controlled phase III trial comparing two arms of patients with underlying liver disease undergoing hepatectomy for HCC by open approach. All patients will have primary abdominal drainage before closure. Patients in the experimental arm will receive a postoperative intravenous infusion of somatostatin during 6 days. Patients in the control group will receive a placebo infusion for the same duration. The primary endpoint will be the presence or absence of postoperative ascites occurring during the 90-day postoperative course, defined as ≥500 ml/24 h of fluid in the drains during at least 3 days or any ascites requiring an invasive procedure comprising percutaneous puncture or drainage. Secondary endpoints will be duration and total volume of ascites, postoperative 90-day mortality and morbidity, liver failure, acute renal failure, length of stay in intensive care unit and hospital stay. The total number of patients to be enrolled was calculated to be 152. DISCUSSION: Postoperative ascites remains a major issue after hepatectomy for HCC as it is associated with increased morbidity, liver and renal failure, the need for specific treatments and prolonged hospital stay. This study represents the first randomized controlled trial to assess the benefits of somatostatin on the risk of postoperative ascites after surgery for HCC. TRIAL REGISTRATION: NCT02799212 (ClinicalTrials.gov identifier). Registered prior to conducting the research on 9 June 2016.

Barriers and facilitators for medication adherence in stroke patients: a qualitative study conducted in French neurological rehabilitation units.

OBJECTIVE: To describe the perceptions of French patients, caregivers and healthcare professionals on stroke and secondary preventive medications. METHOD: A qualitative study was conducted, based on four predetermined topics: stroke, secondary prevention medications, patient's experience, relationship between patient/caregiver and healthcare team. RESULTS: Twenty-six interviews were conducted. Difficulties in taking medications, lack of knowledge on stroke and medication benefits, fear of over medication were identified as barriers for adherence in patients. Doubts about generic drugs were expressed by caregivers. Healthcare professionals reported lack of knowledge and absence of clinical symptoms as barriers. On the other hand, support from caregivers and healthcare professional support is essential for compliance in all participants. Patients and caregivers expressed that fear of recurrence was a facilitator for treatment compliance. CONCLUSION: This study highlights the barriers and facilitators for stroke treatment adherence and underlines the similarities and differences between the perceptions of patients, caregivers and healthcare professionals. These results must be integrated into the future French educational programs to improve medication adherence.

A quantitative and qualitative method to control chemotherapeutic preparations by Fourier transform infrared-ultraviolet spectrophotometry.

Chemotherapy products in hospitals include a reconstitution step of manufactured drugs providing an adapted dosage to each patient. The administration of highly iatrogenic drugs raises the question of patients' safety and treatment efficiency. In order to reduce administration errors due to faulty preparations, we introduced a new qualitative and quantitative routine control based on Fourier Transform Infrared (FTIR) and UV-Visible spectrophotometry. This automated method enabled fast and specific control for 14 anticancer drugs. A 1.2 mL sample was used to assay and identify each preparation in less than 90 sec. Over a two-year period, 9370 controlled infusion bags showed a 1.49% nonconformity rate, under 15% tolerance from the theoretical concentration and 96% minimum identification matching factor. This study evaluated the reliability of the control process, as well as its accordance to chemotherapy deliverance requirements. Thus, corrective measures were defined to improve the control process.

[Cost of functioning of a centralised pharmaceutical unit: evaluation of mean costs of chemotherapy preparations according to the level of production of the unit]. / Coût de fonctionnement d'une unité de reconstitution des cytotoxiques : estimation des besoins en personnel et équipements et estimation du coût moyen d'une préparation selon le niveau de production et d'exigences.

The interest of centralization of preparations of chemotherapy drugs is in addition to its economic aspect, to secure drugs circuit. The aims of this study are to determine needs in employees and equipments of 11 theoretical levels of production from 1,000 to 50,000 preparations per year and to determine the cost of chemotherapy's preparation for each theoretical unit. The operating cost was divided in four areas of expenditure: employees (66-78%), investment (5-15%), maintenance (3-15%) and consumables (4-16%). If we consider the 11 units, the theoretical cost varies between 27.4 € for a unit with 50,000 preparations per year and 114.1 € for a unit with 1,000 preparations per year. This study shows the importance of setting up an optimal unit of preparations according to its activity and highlights the high cost's variation in relation to the activity of the unit.