BackgroundRectal spacers are used to limit dose to the anterior rectal wall in high dose external beam radiation therapy of the prostate and have been shown to reduce radiation induced toxicity. Here we report the complication rate and toxicity of the implantation procedure in a large cohort of patients who have either received a gel- or balloon-type spacer.MethodsIn total, 403 patients received rectal spacing, 264 with balloon, 139 with gel. Allocation was non-randomized. Two hundred seventy-six patients were treated with normofractionated regimen, the remaining 125 patients in moderate hypofractionation. Spacer related acute and late rectal toxicity was prospectively assessed by endoscopy using a mucosa scoring system (Vienna Rectoscopy Score) as well as CTCAE V.4. For the balloon subgroup, position and rotation of balloon spacers were additionally correlated to incidence and grade of rectal reactions in a post-hoc analysis of post-implant planning MRIs.ResultsOverall rectal toxicity was very low with average VRS scores of 0.06 at the day after implantation, 0.10 at the end of RT, 0.31 at 6 months and 0.42 at 12 months follow up. Acute Grade 3 toxicity (rectum perforation and urethral damage) directly related to the implantation procedure occurred in 1.49% (n = 6) and was seen exclusively in patients who had received the spacer balloon. Analysis of post implant MR imaging did not identify abnormal or mal-rotated positions of this spacer to be a predictive factors for the occurrence of spacer related G3 toxicities.ConclusionsSpacer technology is an effective means to minimize dose to the anterior rectal wall. However, the benefits in terms of dose sparing need to be weighed against the low, but possible risks of complications such as rectum perforation.

The combination of ERCP and laparoscopic cholecystectomy offers a safe and effective option for the definitive treatment of complicated gallstone disease and intractable pain during pregnancy, and there is sufficient access for the combined treatment to be employed.

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PurposeThis study was conducted to investigate the potential predictive value of tumor budding for neoadjuvant chemoradiotherapy response in locally advanced rectal cancer.Patients and methodsSurgical specimens of 128 ypUICC (Union for International Cancer Control) stage 0–III mid-to-low rectal cancer patients were identified from a prospectively maintained colorectal cancer database and classified into two groups using the 10 high-power field average method: none/mild tumor budding (BD-0) and moderate/severe tumor budding (BD-1). Overall survival, relapse-free survival (RFS), and recurrence estimates were calculated using the Kaplan–Meier method and compared with the log-rank test. For RFS, a multivariable Cox’s proportional hazards regression analysis was performed.ResultsNo (n = 20) or mild (n = 27) tumor budding (BD-0) was identified in 47 (37%) and moderate (n = 52) or severe (n = 29) tumor budding (BD-1) in 81 (63%) surgical specimens. Positive tumor budding (BD-1) was associated with significantly reduced T‑level downstaging (P < 0.001) and tumor regression (P < 0.001). After a median follow-up time of 7 years (range 2.9–146.7 months), BD-0 patients had more favorable 5‑year RFS (90 vs. 71%, P = 0.02) and distant recurrence (2 vs. 12%, P = 0.03) estimates. Multivariable analyses confirmed BD-1 as a negative predictive parameter for RFS (hazard ratio = 3.44, 95% confidence interval 1.23–9.63, P = 0.018).ConclusionsOur data confirm tumor budding as a strong prognostic factor and its potential predictive value for neoadjuvant chemoradiotherapy response in locally advanced rectal cancer patients. This provides the opportunity to modify and individualize neoadjuvant therapy regimens for non-responders.