Evidence that oral immunoglobulins (KMP01) suppress pro-tumor inflammation in rectal carcinoma: Case report and treatment concept.

BACKGROUND: A female patient aged 49 years with a rectal adenocarcinoma underwent tumor resection and multiple follow-up surgical operations whilst receiving compassionate therapy with polyvalent immunoglobulins derived from bovine colostrum (KMP01), a potential modulator of the pro-tumor inflammatory response. AIMS: Assessment of safety of the treatment, effect on tumor recurrence, and effect on parameters associated with the pro-tumor inflammatory response. MATERIALS AND METHODS: The dose of KMP01 varied from 72 g daily in the perioperative period to 12 - 24 g daily thereafter. The pro-tumor inflammatory response was measured using changes in C-reactive protein (CRP) and the lymphocyte-monocyte ratio (LMR). RESULTS: Surgical intervention caused large increases in CRP (up to 400 mg/L) and decreases in the LMR (below target levels of 2.83). However, such changes rapidly returned to normal, where they remained during prolonged treatment with immunoglobulins. Despite the generally poor prognosis associated with a stenotic tumor, cachexia, and multiple surgery, there was no tumor recurrence during the 3-year follow-up. The condition of the patient is good, albeit with a reduced quality of life due to the stoma. CONCLUSION: Polyvalent immunoglobulins constitute a potential and safe prophylactic agent against the pro-tumor inflammatory response. This is the first time that polyvalent immunoglobulins have been used in a colorectal carcinoma patient. The findings can be a basis for further investigations.

Evaluating a Clinical Pathway in Laparoscopic Cholecystectomy: Effective in Reducing Complications? A Propensity Score Matching Analysis.

BACKGROUND: Care pathways are primarily aimed at decreasing length of hospital stay (LOS) and preventing unnecessary costs while maintaining or improving the quality of care. In laparoscopic cholecystectomy, there is insufficient evidence for proving an impact upon postoperative complications. METHODS: In this retrospective study, logistic regression was used to calculate a propensity score, and, after carrying out 1:1 nearest-neighbor matching, 296 patients were analyzed in both groups with regard to postoperative complications using the Clavien-Dindo classification system as a primary aim. In addition, secondary aims were LOS, compliance to care, and deviation from the care pathway with respect to patient discharge. Relative risk of the primary outcome was calculated and compared with the e-value as sensitivity testing approach. RESULTS: Due to the mandatory part of the care pathway, patient record compliance was 100%. Deviation from the care pathway with respect to the planned patient discharge on postoperative day 2 was noted in 16% of the cases. After adjustment for potential factors, the relative risk when comparing Clavien-Dindo complication grades 0 versus 1-4 is 1.64 (95% CI 0.87-3.11), which did not reach significance (p = 0.127). After matching, LOS lasted 3.69 days without and 3.26 days with the care pathway, respectively. CONCLUSIONS: Against the background of already implemented structured standard operation procedures, a care pathway is not able to reduce postoperative complications. Nevertheless, we consider our clinical pathway a highly valuable tool for the interdisciplinary management of patient hospitalization under the supervision of experienced specialized surgeons.