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Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is a complex procedure with a steep learning curve (LC).
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Using specific statistics with risk adjustment, it was observed that approximately 137 to 180 cases are necessary for the achievement of proficiency considering radicality and safety. Eighty-six to 100 cases were necessary to ensure short-term prognostic gains in rare peritoneal surface malignancies (PSM).
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Centralization of PSM centers is advisable for rare
Learning Curve, Training Program, and Monitorization of Surgical Performance of Peritoneal Surface Malignancies Centers
Section snippets
Key points
The learning curve process
The process of setting up a new PSM is a complex issue whose main limiting factor is that of the LC. The LC could be conceived as the achievement of proficiency in the performance of surgical procedures. This encompasses not only the technical dexterity, but also the ability to select the right case for the surgery and the excellence in the management of the patient in the postoperative period in a multidisciplinary environment.13 Several outcomes could be used for LC evaluation: completeness
Assessment of learning curve using traditional frequentist statistics
Traditional frequentist statistics assess the LC by arbitrarily splitting the cases into different groups. Mohamed and Moran and colleagues14 reported single-surgeon LC in 100 consecutive cases of CRS and HIPEC for PSM dividing the series into three equal groups of consecutive cases and comparing outcomes across groups. They reported a drop in major morbidity and mortality rates from 27% to 0% and 18% to 3%, respectively, from the first to the last group of cases. Similarly, Smeenk and
Statistical process control tests
Although originally developed for quality control of military supplies during World War II, statistical process control tests have been largely used in medicine to monitor the safety of medical interventions, such as interventional cardiology, cardiac surgery, emergency medical services, and other procedures. Two tests are most frequently used: the cumulative sum and sequential probability ratio test (SPRT).17, 18, 19, 20, 21
The SPRT offers an advantage over other statistical process control
The learning curve of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for peritoneal surface malignancies
Kusamura and colleagues13 assessed the LC using RA-SPRT on 420 cases of PSM based on rates of incomplete cytoreduction and G3-5 morbidity (NCI-CTCAE.v3). They estimated the control limits setting the type I/II error rates at 0.05 and unacceptable ORs at 1.8 for incomplete cytoreduction and 1.4 for severe morbidity, based on the literature data. The RA-SPRT curve crossed the lower control limit at the 137th and 149th case, respectively, for incomplete cytoreduction and G3-5 morbidity. At those
How to shorten the learning curve: the role of tutor
The results of Kusamura and colleagues13 and Polanco and colleagues25 confirm that a lengthy LC is required for the acquisition of proficiency in performing CRS and HIPEC. Considering the high morbidity rate and the high cost of the treatment (Santiago González-Moreno, personal communication, 2014), developing strategies to shorten the LC is critically important. Shortening the LC would imply a substantial reduction in the number of adverse events resulting from inexperience, and a reduction in
Which parameter should be used to evaluate learning curve and to monitor surgical performance?
Four outcomes have been used to evaluate LC and surgical performance: (1) incomplete cytoreduction rate, (2) severe morbidity, (3) PRM, and (4) early oncologic failure. Each has pros and cons.
Recently Voron and colleagues27 evaluated the LC of a high-volume center in Paris. The analysis was conducted on a case mix of 290 PSM cases operated with CRS and HIPEC, prevalently composed by PM from colorectal cancer. The outcomes of interest were rates of incomplete cytoreduction and severe morbidity.
Institutional factors affecting learning curve
In the previously mentioned multicentric study, 2451 cases of PMP treated by 47 surgeons in 33 PSM centers from around the world were considered for the LC analysis.29 In the elaboration of multivariate model the authors included not only factors related to biology of the tumor, but also characteristics related to the surgeon’s background and institutions’ organization. The following factors were independent variables related to early oncologic failure: center volume, proportion of PMP, number
Centralization for rare diseases
Kusamura and colleagues31 have conducted the LC analysis on their center’s experience with peritoneal mesothelioma. They adopted the early oncologic failure as target outcome and the breaking point of LC was 86 cases. Given the extremely low incidence of these conditions, it is virtually impossible for a center to gather experience on 100 cases of PMP or 86 of peritoneal mesothelioma, to be considered proficient in the treatment of such rare diseases, unless health care authorities set up
Training program
The ever-growing increase in the number of services offering the combined treatment has occurred in recent decades with neither a well-coded training program and nor regional government regulations. Therefore, it is likely that a significant number of recently emerged low-volume institutions claiming to have the knowhow to manage PSM might not be properly capacitated for this task, because their learning processes are still ongoing. Consequently, the current number of proficient centers in the
Summary
The RA-SPRT is an effective and robust method to monitor surgical performance in the learning and audit phase of a center development. Several factors are associated with surgical performance and the most critical is mentoring of the trainee by an expert in CRS and HIPEC. Parameters related not only to patient and disease but also to logistics and infrastructure of the center could influence prognosis. The latter should be carefully adjusted to further optimize the achievement of center
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Disclosure Statement: The study represented in this article was partially supported by the Italian Association for Cancer Research. AIRC IG 2013 N.14445 and AIRC IG 2016 Id.19206