Assessment of the learning curve for pancreaticoduodenectomy.

BACKGROUND: Experience with the Whipple procedure has been associated with improved outcomes, but the learning curve for this complex procedure is not well defined. METHODS: Outcomes with 162 consecutive Whipple procedures during the 1st 11.5 years of practice was documented in a prospective database. A period of low (≤11/y) and high (≥23/y) case volume was compared using the Wilcoxon rank-sum test and Fisher exact test. RESULTS: With low case volume, blood loss was higher (800 vs 400 mL, P = .001), more patients were transfused (44% vs 18%, P = .027), there were more complications (58% vs 46%, P = .0337), and a longer length of stay (10 vs 7 days, P = .006). There was only 1 mortality (.7%). CONCLUSIONS: Frequent repetition of the Whipple procedure is associated with an improvement in quantifiable quality benchmarks, and improvement continues with extensive experience. However, with proper training and the right environment, this procedure can be performed during the learning curve with acceptable outcomes.

Long-term outcome of EBV-specific T-cell infusions to prevent or treat EBV-related lymphoproliferative disease in transplant recipients.

T-cell immunotherapy that takes advantage of Epstein-Barr virus (EBV)-stimulated immunity has the potential to fill an important niche in targeted therapy for EBV-related cancers. To address questions of long-term efficacy, safety, and practicality, we studied 114 patients who had received infusions of EBV-specific cytotoxic T lymphocytes (CTLs) at 3 different centers to prevent or treat EBV(+) lymphoproliferative disease (LPD) arising after hematopoietic stem cell transplantation. Toxicity was minimal, consisting mainly of localized swelling at sites of responsive disease. None of the 101 patients who received CTL prophylaxis developed EBV(+) LPD, whereas 11 of 13 patients treated with CTLs for biopsy-proven or probable LPD achieved sustained complete remissions. The gene-marking component of this study enabled us to demonstrate the persistence of functional CTLs for up to 9 years. A preliminary analysis indicated that a patient-specific CTL line can be manufactured, tested, and infused for $6095, a cost that compares favorably with other modalities used in the treatment of LPD. We conclude that the CTL lines described here provide safe and effective prophylaxis or treatment for lymphoproliferative disease in transplantation recipients, and the manufacturing methodology is robust and can be transferred readily from one institution to another without loss of reproducibility.