Feasibility of a fast-track randomized controlled trial of cell-free and concentrated ascites reinfusion therapy for patients with refractory malignant ascites.

BACKGROUND: Malignant ascites often causes discomfort in advanced cancer patients. Paracentesis is the most common treatment modality, but it requires frequently repeated treatment. Cell-free and concentrated ascites reinfusion therapy (CART) may prolong the paracentesis interval, but controlled trials are lacking. We assessed the feasibility of a randomized controlled trial of CART vs. paracentesis alone for patients with refractory malignant ascites. METHODS: This study was an open-label, fast-track, randomized controlled, feasibility trial. Patients admitted to four designated cancer hospitals who received no further anticancer treatments were eligible. Patients were randomly assigned 1:1 to a CART arm or control (simple paracentesis) arm. The feasibility endpoint was the percentage of patients who completed the study intervention. Secondary endpoints included paracentesis-free survival, patient's request on the questionnaire for paracentesis (PRO-paracentesis)-free survival (the period until the patients first reported that they would want paracentesis if indicated), and adverse events. RESULTS: We screened 953 patients for eligibility. Of 61 patients with refractory malignant ascites, 21 patients were determined as eligible. Finally, 20 patients consented and were allocated; 18 patients (90%, 95% CI: 68.3-98.8) completed the study intervention. All patients had an ECOG performance status of 3 or 4. The median drained ascites volume was 3,200 mL in the CART arm and 2,500 mL in the control arm. In the CART arm, the median reinfused albumin volume was 12.6 g. Median paracentesis-free survivals were 5 days (95% CI: 2-6) in the CART arm, and 6 days (3-9) in the control arm. Median PRO-paracentesis-free survivals were 4 days (2-5) and 5 days (1-9), respectively. A total of 73% of patients received paracentesis within 2 days from their first request for the next paracentesis. One patient in the CART arm developed Grade 1 fever. CONCLUSIONS: A fast-track randomized controlled trial of CART for patients with malignant ascites is feasible. The efficacy and safety of CART should be assessed in future trials. PRO-paracentesis-free survival may be a complementary outcome measure with paracentesis-free survival in future trials. TRIAL REGISTRATION: Registered at University Hospital Medical Information Network Clinical Trial Registry as UMIN000031029 . Registered on 28/01/2018.

[Anaphylactic shock secondary to the use of macrogol 4000 as a bowel cleanser:a case report].

A 44-year-old man was administered Niflec® containing macrogol 4000 as a bowel cleanser for colonoscopic examination. Immediately after ingestion, he experienced oral cavity discomfort and nasal congestion, followed by acute urticaria and presyncope. His systolic blood pressure and peripheral capillary oxygen saturation dropped to 66mmHg and 89%, respectively. Fluid infusion, as well as steroid and epinephrine administration, improved his symptoms. Skin prick tests were then performed using Niflec®, macrogol 4000, and Actosin® ointment (containing macrogol 4000), all of which were positive. Therefore, the patient was diagnosed with anaphylactic shock caused by macrogol 4000 included in Niflec®. Macrogol present in bowel cleansers used for colonoscopy rarely causes anaphylactic shock. However, clinicians need to be mindful of this risk. Prompt and appropriate treatment is needed should this condition occur.

Plasmablastic lymphoma occurring in ulcerative colitis during treatment with immunosuppressive therapy.

A 53-year-old man who had a history of ulcerative colitis (UC) for 2 years underwent colonoscopy as regular follow-up. The results showed an elevated lesion in the descending colon, which was diagnosed as plasmablastic lymphoma (PBL) based on pathological findings. In situ hybridization for the Epstein-Barr virus-encoded RNA probe was positive. Fluorescence in situ hybridization revealed rearrangement of the MYC gene. He had been taking prednisolone, 5-aminosalicylic acid, azathiopurine, and ustekinumab at the diagnosis of PBL and had multiple prior therapies for UC including infliximab, tacrolimus, and tofacitinib due to steroid dependence. PBL is a rare aggressive B cell lymphoma initially described in the oral cavity of human immunodeficiency virus positive patients and it is suspected to have an association with immunocompromised status of patients. The number of cases of PBL in inflammatory bowel disease (IBD) patients is extremely rare. All these patients were administered immunosuppressive therapy including thiopurines or biologics. IBD patients with immunosuppressive therapy have a higher potential for developing lymphoproliferative disorders. Clinicians should be aware of the risk of lymphoma, including PBL.

Expectations of respiratory physicians from psychologists in palliative care for patients with non-cancer respiratory diseases.

BACKGROUND: Psychological symptoms are common in patients with non-malignant respiratory disease (NMRD). Psychologists can likely play a role in NMRD palliative care. We aimed to explore the expectations of respiratory physicians from psychologists in NMRD palliative care. METHODS: An ad hoc questionnaire was developed based on a free-descriptive questionnaire survey among respiratory physicians from four hospitals in Japan. Using this questionnaire, we surveyed respiratory physicians from eight hospitals in Japan and assessed their expectations of psychologists' support and outcomes. Expectations were compared between physicians with and without experience of working with psychologists. RESULTS: The quantitative questionnaire was completed by 129 physicians. Data analysis from 108 participants revealed that the highly expected support included "getting early information on patients' psychological distress" (97.2%) and "counseling family members regarding anxiety caused by changes in patient's condition" (96.3%). Physicians also expected "relief in patient's psychological distress" (96.3%) and "providing the psychological support that families need" (95.4%) from psychologists. Compared to physicians with experience of working with psychologists, those without expected more in terms of "giving specific advice on the way of communication and psychological support" (p = 0.035) and "providing psychological support for difficult-to-handle patients and families on behalf of other medical staff" (p = 0.036). CONCLUSIONS: Respiratory physicians may expect relief of psychological distress experienced by patients and their families from psychologists by getting information about their distress and providing psychological support. These results may be useful for psychologists to provide palliative care for patients with NMRD in collaboration with respiratory physicians.

Renal Dysfunction is an Independent Risk Factor for Rebleeding After Endoscopic Hemostasis in Patients with Peptic Ulcer Bleeding.

BACKGROUND: Despite the progress in endoscopic hemostasis and pharmacological treatment, the mortality rate of peptic ulcer bleeding remains at 5-10%. Rebleeding after peptic ulcer bleeding is believed to be a risk factor for mortality. This study aimed to evaluate whether renal dysfunction is a predictor of rebleeding after endoscopic hemostasis in patients with peptic ulcer bleeding. METHODS: In this retrospective study, consecutive patients with peptic ulcer bleeding who underwent endoscopic hemostasis at our Hospital from January 2010 to December 2018 were enrolled. The relationship between rebleeding within 30 days after endoscopic hemostasis and the patients' admission and endoscopic characteristics were analyzed using univariate and multivariate regression models. RESULTS: Out of 274 patients with peptic ulcer bleeding, 17 (6.2%) patients experienced rebleeding. In the analysis of the patients' admission characteristics, estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 was an independent risk factor for rebleeding (odds ratio 4.77, 95% confidence interval 1.168-18.211, p = 0.03). Patients with eGFR < 15 mL/min/1.73 m2 with or without hemodialysis had the highest rebleeding rate at 36.8%. With respect to endoscopic characteristics, the rate of rebleeding was associated with combination therapy (p < 0.0001) and active bleeding (p = 0.03). CONCLUSION: Renal dysfunction might be an independent risk factor for rebleeding after endoscopic hemostasis in patients with peptic ulcer bleeding.

[A case of type 4 gastric cancer with peritoneal dissemination complicating venous thromboembolism treated effectively by combination of S-1 and warfarin].

A 49-year-old female patient was admitted to our hospital for a type 4 gastric cancer with peritoneal dissemination. Two courses of paclitaxel (PTX), and eight courses of S-1 were carried out. Although a partial response was obtained, she had complications with a deep venous thromboembolism (DVT) and pulmonary embolism (PE) during the treatment. Heparin, followed by warfarin, was useful to treat the embolism. After the venous thromboembolism (VTE) disappeared, combination therapy with S-1 and warfarin were started, and the quality of life (QOL) of this patient was maintained for about one year. Fine monitoring of the international normalized ratio (INR) was required in order to prevent side effects of blood coagulation by S-1 and warfarin coadministration. This case suggests that the combination therapy of S-1 and warfarin may be a safe and effective treatment able to prolong time to progression against a type 4 gastric cancer with VTE.

Prophylactic clip closure may reduce the risk of delayed bleeding after colorectal endoscopic submucosal dissection.

BACKGROUND AND STUDY AIMS: Endoscopic submucosal dissection (ESD) has a high en bloc resection rate and is widely performed for large superficial colorectal tumors, but delayed bleeding remains one of the most common complications of colorectal ESD. The aim of the present study was to evaluate the clinical efficacy of prophylactic clip closure of mucosal defects for the prevention of delayed bleeding after colorectal ESD. PATIENTS AND METHODS: We enrolled consecutive patients with colorectal lesions between January 2012 and May 2017 in this retrospective study. In the early part of this period, post-ESD mucosal defects were not closed (non-closure group); however, from January 2014, post-ESD mucosal defects were prophylactically closed with clips when possible (closure group). The main outcome measured was delayed bleeding. Variables were analyzed using the chi-squared test, Fisher's exact test, or Student's t-test. RESULTS: Of 156 lesions analyzed, 61 were in the non-closure group and 95 in the closure group. Overall, delayed bleeding occurred in 5 cases (3.2 %). The delayed bleeding rate was 0 % (0/95) in the closure group and 8.2 % (5/61) in the non-closure group ( P  = 0.008). The mean procedure time for closure was 10.4 ±â€Š4.6 min (range 3 - 26 min). CONCLUSIONS: We demonstrated that prophylactic clip closure of mucosal defects might reduce the risk of delayed bleeding after colorectal ESD.

Acute tumor lysis syndrome caused by palliative radiotherapy in patients with diffuse large B-cell lymphoma.

Acute tumor lysis syndrome (TLS) is a condition that results from the rapid destruction of tumor cells accompanied with a massive release of cellular breakdown products. Acute renal failure resulting from TLS has been reported in cases of hematologic malignancies, spontaneous or treatment induced, the latter especially by chemotherapy. We present the case of a patient with diffuse large B-cell lymphoma who developed radiotherapy-induced TLS and subsequently acute renal failure. He presented with a large mediastinal tumor compressing the airway, thus causing dyspnea. After 6 Gy/3 fractions/3 days of palliative radiotherapy for the tumor, a decrease in urine volume was noted as well as rapid tumor shrinking. Because this patient died despite previous prophylaxic anti-uric acid treatment and hemodialysis, his case illustrates the need to anticipate the development of acute renal failure, even though there may be no remarkable serum uric acid elevation after the initiation of radiotherapy.