Triple modal treatment comprising with proton beam radiation, hyperthermia, and gemcitabine/nab-paclitaxel for locally advanced pancreatic cancer: a phase I/II study protocol (TT-LAP trial).

BACKGROUND: Locally advanced pancreatic ductal adenocarcinoma (PDAC), accounting for about 30% of PDAC patients, is difficult to cure by radical resection or systemic chemotherapy alone. A multidisciplinary strategy is required and our TT-LAP trial aims to evaluate whether triple-modal treatment with proton beam therapy (PBT), hyperthermia, and gemcitabine plus nab-paclitaxel is a safe and synergistically effective treatment for patients with locally advanced PDAC. METHODS: This trial is an interventional, open-label, non-randomized, single-center, single-arm phase I/II clinical trial organized and sponsored by the University of Tsukuba. Eligible patients who are diagnosed with locally advanced pancreatic cancer, including both borderline resectable (BR) and unresectable locally advanced (UR-LA) patients, and selected according to the inclusion and exclusion criteria will receive triple-modal treatment consisting of chemotherapy, hyperthermia, and proton beam radiation. Treatment induction will include 2 cycles of chemotherapy (gemcitabine plus nab-paclitaxel), proton beam therapy, and 6 total sessions of hyperthermia therapy. The initial 5 patients will move to phase II after adverse events are verified by a monitoring committee and safety is ensured. The primary endpoint is 2-year survival rate while secondary endpoints include adverse event rate, treatment completion rate, response rate, progression-free survival, overall survival, resection rate, pathologic response rate, and R0 (no pathologic cancer remnants) rate. The target sample size is set at 30 cases. DISCUSSION: The TT-LAP trial is the first to evaluate the safety and effectiveness (phases1/2) of triple-modal treatment comprised of proton beam therapy, hyperthermia, and gemcitabine/nab-paclitaxel for locally advanced pancreatic cancer. ETHICS AND DISSEMINATION: This protocol was approved by the Tsukuba University Clinical Research Review Board (reference number TCRB22-007). Results will be analyzed after study recruitment and follow-up are completed. Results will be presented at international meetings of interest in pancreatic cancer plus gastrointestinal, hepatobiliary, and pancreatic surgeries and published in peer-reviewed journals. TRIAL REGISTRATION: Japan Registry of Clinical Trials, jRCTs031220160. Registered 24 th June 2022, https://jrct.niph.go.jp/en-latest-detail/jRCTs031220160 .

Impact of the clinical use of artificial intelligence-assisted neoplasia detection for colonoscopy: a large-scale prospective, propensity score-matched study (with video).

BACKGROUND AND AIMS: Recently, the use of computer-aided detection (CADe) for colonoscopy has been investigated to improve the adenoma detection rate (ADR). We aimed to assess the efficacy of a regulatory-approved CADe in a large-scale study with high numbers of patients and endoscopists. METHODS: This was a propensity score-matched prospective study that took place at a university hospital between July 2020 and December 2020. We recruited patients aged ≥20 years who were scheduled for colonoscopy. Patients with polyposis, inflammatory bowel disease, or incomplete colonoscopy were excluded. We used a regulatory-approved CADe system and conducted a propensity score matching-based comparison of the ADR between patients examined with and without CADe as the primary outcome. RESULTS: During the study period, 2261 patients underwent colonoscopy with the CADe system or routine colonoscopy, and 172 patients were excluded in accordance with the exclusion criteria. Thirty endoscopists (9 nonexperts and 21 experts) were involved in this study. Propensity score matching was conducted using 5 factors, resulting in 1836 patients included in the analysis (918 patients in each group). The ADR was significantly higher in the CADe group than in the control group (26.4% vs 19.9%, respectively; relative risk, 1.32; 95% confidence interval, 1.12-1.57); however, there was no significant increase in the advanced neoplasia detection rate (3.7% vs 2.9%, respectively). CONCLUSIONS: The use of the CADe system for colonoscopy significantly increased the ADR in a large-scale prospective study including 30 endoscopists (Clinical trial registration number: UMIN000040677.).

Double Coaxial Microcatheter Technique for Glue Embolization of Renal Arteriovenous Malformations.

PURPOSE: To demonstrate the technical benefit of the double coaxial microcatheter technique for embolization of renal arteriovenous malformations (AVMs) with n-butyl cyanoacrylate and iodized oil (glue). MATERIALS AND METHODS: Six consecutive patients (1 man and 5 women; mean age 61 years; range 44-77 years) with renal AVMs were included. Five patients had hematuria, and one had a risk of heart failure due to a large intrarenal arteriovenous shunt. All patients underwent transarterial embolization using glue and the double coaxial microcatheter technique with outer 2.6F and inner 1.9F microcatheters. After glue injection, the inner microcatheter was retracted, while the outer microcatheter was retained. We assessed the complications and clinical outcomes of this technique. RESULTS: Technical success was achieved in all patients. In 9 sessions, 34 feeding arteries were embolized with glue using the double coaxial microcatheter technique, 1 was embolized with glue using a single microcatheter, and 2 were embolized with coils. The double coaxial microcatheter technique was useful for selecting small tortuous feeding arteries, preventing glue reflux to the proximal arteries, and approaching multiple feeding arteries without complete retraction of the microcatheters. As a minor complication, glue migrated into the venous system in four patients without any sequelae. In all patients, favorable clinical outcomes, including hematuria cessation in five patients and improvement of the large intrarenal arteriovenous shunt in one patient, were obtained without deterioration of renal function. CONCLUSION: Glue embolization with the double coaxial microcatheter technique was useful for treating renal AVMs with multiple tortuous feeding arteries.