Multicenter, prospective, observational study of chemotherapy-induced dysgeusia in gastrointestinal cancer.

PURPOSE: Dysgeusia is an adverse event caused by chemotherapy. Although retrospective studies have shown zinc administration improves dysgeusia, there have been no prospective studies. The present study examined effects of zinc therapy on dysgeusia in patients with gastrointestinal cancer. METHODS: This multicenter, prospective, observational study enrolled patients with dysgeusia during chemotherapy treatment. Patients received no intervention (control), polaprezinc p.o., or zinc acetate hydrate p.o., and serum zinc levels were measured at 0 (baseline), 6, and 12 weeks. Dysgeusia was assessed using CTCAE v5.0 and subjective total taste acuity (STTA) criteria using questionnaires at baseline and 12 weeks. RESULTS: From February 2020 to June 2021, 180 patients were enrolled from 17 institutes. There were no differences in mean baseline serum zinc levels among the groups (67.3, 66.6, and 67.5 µg/dL in the no intervention, polaprezinc, and zinc acetate hydrate groups, respectively. P = 0.846). The changes in mean serum zinc levels after 12 weeks were - 3.8, + 14.3, and + 46.6 µg/dL, and the efficacy rates of dysgeusia were 33.3%, 36.8%, and 34.6% using CTCAE and 33.3%, 52.6%, 32.7% using STTA in the no intervention, polaprezinc, and zinc acetate hydrate groups, respectively. The STTA scores improved in all groups, with significant improvement observed in the polaprezinc group compared with the no intervention group (P = 0.045). CONCLUSION: There was no significant correlation between the degree of serum zinc elevation and improvement in dysgeusia, suggesting that polaprezinc, but not zinc acetate hydrate, was effective in improving chemotherapy-induced dysgeusia. TRIAL REGISTRATION: UMIN000039653. Date of registration: March 2, 2020.

Non-negligible rate of needle tract seeding after endoscopic ultrasound-guided fine-needle aspiration for patients undergoing distal pancreatectomy for pancreatic cancer.

BACKGROUND AND AIMS: Needle tract seeding after preoperative endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) for pancreatic body and tail cancer has been reported. This study aimed to investigate the long-term outcomes, including the needle tract seeding ratio, of patients undergoing distal pancreatectomy for pancreatic body and tail cancer diagnosed preoperatively by EUS-FNA. METHODS: This retrospective, observational cohort study assessed patients from three university hospitals and 11 tertiary referral centers. All patients who underwent distal pancreatectomy for invasive cancer of the pancreatic body and tail between January 2006 and December 2015 were identified and reviewed. Needle tract seeding rate, recurrence-free survival (RFS), and overall survival (OS) were evaluated. RESULTS: Of the 301 total patients analyzed, 176 underwent preoperative EUS-FNA (EUS-FNA group) and 125 did not (non-EUS-FNA group). The median follow-up periods of the EUS-FNA group and non-EUS-FNA group were 32.8 and 30.1 months. Six patients (3.4%) in the EUS-FNA group were diagnosed as having needle tract seeding. The 5-year cumulative needle tract seeding rate estimated using Fine and Gray's method was 3.8% (95% CI 1.6-7.8%). The median RFS or OS was not significantly different between the EUS-FNA group and the non-EUS-FNA group (23.7 vs 16.9 months: P = 0.205; 48.0 vs 43.9 months: P = 0.392). CONCLUSION: Although preoperative EUS-FNA for pancreatic body and tail cancer has no negative effect on RFS or OS, needle tract seeding after EUS-FNA was observed to have a non-negligible rate. (UMIN000030719).

A Prospective Multicenter Study Evaluating Bleeding Risk after Endoscopic Ultrasound-Guided Fine Needle Aspiration in Patients Prescribed Antithrombotic Agents.

BACKGROUND/AIMS: Although the risk of bleeding after endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is low, the safety of EUS-FNA in patients prescribed antithrombotic agents is unclear. Therefore, this study evaluated the incidence of bleeding after EUS-FNA in those patients. METHODS: Between September 2012 and September 2015, patients who were prescribed antithrombotic agents underwent EUS-FNA at 13 institutions in Japan were prospectively enrolled in the study. The antithrombotic agents were managed according to the guidelines of the Japanese Gastrointestinal Endoscopy Society. The rate of bleeding events, thromboembolic events and other complications within 2 weeks after EUS-FNA were analyzed. RESULTS: Of the 2,629 patients who underwent EUS-FNA during the study period, 85 (62 males; median age, 74 years) patients were included in this stduy. Two patients (2.4%; 95% confidence interval [CI], 0.6% to 8.3%) experienced bleeding events. One patient required surgical intervention for hemothorax 5 hours after EUS-FNA, and the other experienced melena 8 days after EUS-FNA and required red blood cell transfusions. No thromboembolic events occurred (0%; 95% CI, 0.0% to 4.4%). Three patients (3.5%; 95% CI, 1.2% to 10.0%) experienced peri-puncture abscess formation. CONCLUSIONS: The rate of bleeding after EUS-FNA in patients prescribed antithrombotic agents might be considerable.

[Clinical efficacy of adalimumab for a postoperative marginal ulcer in gastrointestinal Behçet disease].

A 63-year-old woman with Behçet disease presented with epigastric pain due to refractory gastric ulcers. Examinations indicated that these ulcers were caused by gastrointestinal Behçet disease. Steroid therapy proved ineffective, so we gave 5mg/kg of infliximab. However, since the patient responded poorly to the treatment the infliximab was discontinued and a total gastrectomy was performed. After surgery, a marginal ulcer developed and infliximab was again administered. Although this brought about improvement in the conditions of the marginal ulcer, infusion-related hypersensitivities in the patient caused polyarthralgia. We therefore discontinued the infliximab treatment and began 40 mg of adalimumab every other week. After 3 months of the new treatment, the patient's marginal ulcer completely healed and her epigastric pain disappeared. This case suggests that adalimumab may be as useful as infliximab for treating refractory gastrointestinal Behçet disease.

[Osteoclast-like giant cell tumor (OGCT) of the liver: report of a case].

A 57-year-old man presented with jaundice. Abdominal computed tomography showed a 10-cm left hepatic lobe heterogeneous solid mass with low attenuated areas in the mass, multiple liver metastases and lung metastasis. Serology for hepatitis B and C were negative. Serum alpha-fetoprotein, CEA and CA19-9 were normal. The patient died a few weeks later of progressive liver failure and an autopsy was performed. Histologically, the tumor consisted of sarcomatoid mononuclear cells and osteoclast-like giant cells. The liver tissue surrounding the tumor showed no cirrhotic pattern. The osteoclast-like giant cells were uniformly and strongly immunoreactive with CD68. The mononuclear cells demonstrated expression of vimentin but were negative for CAM5.2. The MIB-1 index was 20% for the mononuclear cells. In conclusion, the histopathological diagnosis revealed an osteoclast-like giant cell tumor of the liver.

Impact of changing our cannulation method on the incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis after pancreatic guidewire placement.

AIM: To clarify whether the incidence of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) after pancreatic guidewire placement (PGW) can be reduced by using a different cannulation method. METHODS: Between April 2001 and October 2009, PGW was performed in 142 patients with native papilla to overcome difficult biliary cannulation. Our cannulation method for ERCP was changed from contrast injection (CI) using a single-lumen catheter (April 2001-May 2008) to wire-guided cannulation (WGC) using a double-lumen catheter (June 2008-October 2009). The CI protocol was also changed during the study period: in the first period it was used for routine pancreatography for detecting small pancreatic cancer (April 2001-November 2002), whereas in the second period it was not (December 2002-May 2008). In PGW with CI using a single-lumen catheter, the contrast medium in the catheter lumen was injected into the pancreatic duct. The success rate of biliary cannulation, the incidence of PEP according to the cannulation method, and the impact of CI using a single-lumen catheter on PEP in comparison with WGC using a double-lumen catheter were investigated. RESULTS: CI with routine pancreatography, CI without routine pancreatography, and WGC were performed in 27 patients, 77 patients and 38 patients, respectively. Routine pancreatography did not contribute to the early diagnosis of pancreatic cancer in our study period. In CI without routine pancreatography and WGC, diagnostic pancreatography was performed in 17 patients and no patients, respectively. The success rate of biliary cannulation by PGW alone was 69%, and the final success rate was increased to 80.3% by the addition of consecutive maneuvers or a second ERCP. PEP occurred in 22 patients (15.5%), and the severity was mild in all cases. When analyzed according to cannulation method, the incidence of PEP was 37.0% (10/27) in the patients who underwent CI with routine pancreatography, 14.3% (11/77) in those who underwent CI without routine pancreatography, and 2.6% (1/38) in those who underwent WGC. In all patients who underwent CI using a single-lumen catheter, the incidence of PEP was 20% (21/104), which was significantly higher than that in WGC using a double-lumen catheter. In univariate and multivariate analysis, CI using a single-lumen catheter showed a high, statistically significant, odds ratio for PEP after PGW. CONCLUSION: The practice of a cannulation method involving the use of a double-lumen catheter minimizes the CI dose administered to the pancreatic duct and reduces the incidence of PEP after PGW.