Impact of 18FFDG-PET/CT and Laparoscopy in Staging of Locally Advanced Gastric Cancer: A Cost Analysis in the Prospective Multicenter PLASTIC-Study.

BACKGROUND: Unnecessary D2-gastrectomy and associated costs can be prevented after detecting non-curable gastric cancer, but impact of staging on treatment costs is unclear. This study determined the cost impact of 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18FFDG-PET/CT) and staging laparoscopy (SL) in gastric cancer staging. MATERIALS AND METHODS: In this cost analysis, four staging strategies were modeled in a decision tree: (1) 18FFDG-PET/CT first, then SL, (2) SL only, (3) 18FFDG-PET/CT only, and (4) neither SL nor 18FFDG-PET/CT. Costs were assessed on the basis of the prospective PLASTIC-study, which evaluated adding 18FFDG-PET/CT and SL to staging advanced gastric cancer (cT3-4 and/or cN+) in 18 Dutch hospitals. The Dutch Healthcare Authority provided 18FFDG-PET/CT unit costs. SL unit costs were calculated bottom-up. Gastrectomy-associated costs were collected with hospital claim data until 30 days postoperatively. Uncertainty was assessed in a probabilistic sensitivity analysis (1000 iterations). RESULTS: 18FFDG-PET/CT costs were €1104 including biopsy/cytology. Bottom-up calculations totaled €1537 per SL. D2-gastrectomy costs were €19,308. Total costs per patient were €18,137 for strategy 1, €17,079 for strategy 2, and €19,805 for strategy 3. If all patients undergo gastrectomy, total costs were €18,959 per patient (strategy 4). Performing SL only reduced costs by €1880 per patient. Adding 18FFDG-PET/CT to SL increased costs by €1058 per patient; IQR €870-1253 in the sensitivity analysis. CONCLUSIONS: For advanced gastric cancer, performing SL resulted in substantial cost savings by reducing unnecessary gastrectomies. In contrast, routine 18FFDG-PET/CT increased costs without substantially reducing unnecessary gastrectomies, and is not recommended due to limited impact with major costs. TRIAL REGISTRATION: NCT03208621. This trial was registered prospectively on 30-06-2017.

The value of C-reactive protein, leucocytes and vital signs in detecting major complications after oncological colorectal surgery.

PURPOSE: To assess the association of postoperative C-reactive protein (CRP), leucocytes and vital signs in the first three postoperative days (PODs) with major complications after oncological colorectal resections in a tertiary referral centre for colorectal cancer in The Netherlands. METHODS: A retrospective cohort study, including 594 consecutive patients who underwent an oncological colorectal resection at Maastricht University Medical Centre between January 2016 and December 2020. Descriptive analyses of patient characteristics were performed. Logistic regression models were used to assess associations of leucocytes, CRP and Modified Early Warning Score (MEWS) at PODs 1-3 with major complications. Receiver operating characteristic curve analyses were used to establish cut-off values for CRP. RESULTS: A total of 364 (61.3%) patients have recovered without any postoperative complications, 134 (22.6%) patients have encountered minor complications and 96 (16.2%) developed major complications. CRP levels reached their peak on POD 2, with a mean value of 155 mg/L. This peak was significantly higher in patients with more advanced stages of disease and patients undergoing open procedures, regardless of complications. A cut-off value of 170 mg/L was established for CRP on POD 2 and 152 mg/L on POD 3. Leucocytes and MEWS also demonstrated a peak on POD 2 for patients with major complications. CONCLUSIONS: Statistically significant associations were found for CRP, Δ CRP, Δ leucocytes and MEWS with major complications on POD 2. Patients with CRP levels ≥ 170 mg/L on POD 2 should be carefully evaluated, as this may indicate an increased risk of developing major complications.

Surgical treatment of anorectal melanoma: a systematic review and meta-analysis.

BACKGROUND: Anorectal melanoma is a rare neoplasm with a poor prognosis. The surgical approaches for anorectal melanoma can be categorized into local excision (procedures without lymph node removal and preservation of the rectum) and extensive resection (procedures with rectum and pararectal lymph node removal). The aim of this systematic review and meta-analysis was to compare the survival of patients who underwent extensive resection with that of patients who underwent local excision, stratifying patients according to tumour stage. METHODS: A literature review was performed according to PRISMA guidelines by searching MEDLINE/PubMed for manuscripts published until March 2021. Studies comparing survival outcomes in patients with anorectal melanoma who underwent local excision versus extensive resection were screened for eligibility. Meta-analysis was performed for overall survival after the different surgical approaches, stratified by tumour stage. RESULTS: There were 347 studiesidentified of which 34 were included for meta-analysis with a total of 1858 patients. There was no significant difference in overall survival between the surgical approaches in patients per stage (stage I odds ratio 1.30 (95 per cent c.i. 0.62 to 2.72, P = 0.49); stage II odds ratio 1.61 (95 per cent c.i. 0.62 to 4.18, P = 0.33); stage I-III odds ratio 1.19 (95 per cent c.i. 0.83 to 1.70, P = 0.35). Subgroup analyses were conducted for the time intervals (<2000, 2001-2010 and 2011-2021) and for continent of study origin. Subgroup analysis for time interval and continent of origin also showed no statistically significant differences in overall survival. CONCLUSION: No significant survival benefit exists for patients with anorectal melanoma treated with local excision or extensive resection, independent of tumour stage.

18F-Fludeoxyglucose-Positron Emission Tomography/Computed Tomography and Laparoscopy for Staging of Locally Advanced Gastric Cancer: A Multicenter Prospective Dutch Cohort Study (PLASTIC).

Importance: The optimal staging for gastric cancer remains a matter of debate. Objective: To evaluate the value of 18F-fludeoxyglucose-positron emission tomography with computed tomography (FDG-PET/CT) and staging laparoscopy (SL) in addition to initial staging by means of gastroscopy and CT in patients with locally advanced gastric cancer. Design, Setting, and Participants: This multicenter prospective, observational cohort study included 394 patients with locally advanced, clinically curable gastric adenocarcinoma (≥cT3 and/or N+, M0 category based on CT) between August 1, 2017, and February 1, 2020. Exposures: All patients underwent an FDG-PET/CT and/or SL in addition to initial staging. Main Outcomes and Measures: The primary outcome was the number of patients in whom the intent of treatment changed based on the results of these 2 investigations. Secondary outcomes included diagnostic performance, number of incidental findings on FDG-PET/CT, morbidity and mortality after SL, and diagnostic delay. Results: Of the 394 patients included, 256 (65%) were men and mean (SD) age was 67.6 (10.7) years. A total of 382 patients underwent FDG-PET/CT and 357 underwent SL. Treatment intent changed from curative to palliative in 65 patients (16%) based on the additional FDG-PET/CT and SL findings. FDG-PET/CT detected distant metastases in 12 patients (3%), and SL detected peritoneal or locally nonresectable disease in 73 patients (19%), with an overlap of 7 patients (2%). FDG-PET/CT had a sensitivity of 33% (95% CI, 17%-53%) and specificity of 97% (95% CI, 94%-99%) in detecting distant metastases. Secondary findings on FDG/PET were found in 83 of 382 patients (22%), which led to additional examinations in 65 of 394 patients (16%). Staging laparoscopy resulted in a complication requiring reintervention in 3 patients (0.8%) without postoperative mortality. The mean (SD) diagnostic delay was 19 (14) days. Conclusions and Relevance: This study's findings suggest an apparently limited additional value of FDG-PET/CT; however, SL added considerably to the staging process of locally advanced gastric cancer by detection of peritoneal and nonresectable disease. Therefore, it may be useful to include SL in guidelines for staging advanced gastric cancer, but not FDG-PET/CT.

Double venipuncture is not required for adequate S-100B determination in melanoma patients.

S-100B is used in melanoma follow-up. This serum biomarker is also present in adipocytes; therefore, subcutaneous adipocytes trapped in the needle before performing a venipuncture could contaminate the serum. The aim was to study the influence of adipocyte contamination on blood samples used for S-100B analysis, possibly resulting in falsely elevated S-100B values. A total of 294 serum samples were collected from 147 American Joint Committee on Cancer staging stage III melanoma patients. The mean difference between the first (dummy) and second tubes was 0.003 µg/l (p = 0.077), with a decrease in the second tube. Compared with the second tube, the S-100B level was higher in the first tube in 33.3% of the samples, equal in 36.8% of the samples and lower in 29.9% of the samples. No significant difference between the two consecutively drawn tubes was found. There seems to be no necessity of implementing a dummy tube system for accurate S-100B determination in melanoma patients.

S-100B as an extra selection tool for FDG PET/CT scanning in follow-up of AJCC stage III melanoma patients.

BACKGROUND AND OBJECTIVES: This current study assessed the value of S-100B measurement to guide fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) scanning for detecting recurrent disease in stage III melanoma patients. METHODS: This study included 100 stage III melanoma patients in follow-up after curative lymph node dissection. Follow-up visits included physical examination and S-100B monitoring. FDG PET/CT scanning was indicated by clinical symptoms and/or elevated S-100B. RESULTS: Of 100 patients, 13 (13%) had elevated S-100B without clinical symptoms, of whom 7 (54%) showed disease evidence upon FDG PET/CT scanning. Twenty-six patients (26%) had clinical symptoms with normal S-100B and FDG PET/CT revealed metastasis in 20 (77%). Three patients had clinical symptoms and elevated S-100B, and FDG PET/CT revealed metastasis in all three (100%). Overall, FDG PET/CT scanning revealed metastasis in 30 of the 42 patients (71.4%). For seven recurrences, elevated S-100B prompted early detection of asymptomatic disease; 10% of all asymptomatic patients in follow-up, 23% of all patients with recurrent disease. CONCLUSION: S-100B cannot exclude recurrent disease during follow-up of stage III melanoma. However, adding S-100B measurement to standard clinical assessment can guide FDG PET/CT scanning for detecting recurrent melanoma.

Laparoscopy Instructional Videos: The Effect of Preoperative Compared With Intraoperative Use on Learning Curves.

OBJECTIVE: Previous studies have shown that the use of intraoperative instructional videos has a positive effect on learning laparoscopic procedures. This study investigated the effect of the timing of the instructional videos on learning curves in laparoscopic skills training. DESIGN: After completing a basic skills course on a virtual reality simulator, medical students and residents with less than 1 hour experience using laparoscopic instruments were randomized into 2 groups. Using an instructional video either preoperatively or intraoperatively, both groups then performed 4 repetitions of a standardized task on the TrEndo augmented reality. With the TrEndo, 9 motion analysis parameters (MAPs) were recorded for each session (4 MAPs for each hand and time). These were the primary outcome measurements for performance. The time spent watching the instructional video was also recorded. Improvement in performance was studied within and between groups. SETTING: Medical Center Leeuwarden, a secondary care hospital located in Leeuwarden, The Netherlands. PARTICIPANTS: Right-hand dominant medical student and residents with more than 1 hour experience operating any kind of laparoscopic instruments were participated. A total of 23 persons entered the study, of which 21 completed the study course. RESULTS: In both groups, at least 5 of 9 MAPs showed significant improvements between repetition 1 and 4. When both groups were compared after completion of repetition 4, no significant differences in improvement were detected. The intraoperative group showed significant improvement in 3 MAPs of the left-nondominant-hand, compared with one MAP for the preoperative group. CONCLUSION: No significant differences in learning curves could be detected between the subjects who used intraoperative instructional videos and those who used preoperative instructional videos. Intraoperative video instruction may result in improved dexterity of the nondominant hand.

Nodular Histologic Subtype and Ulceration are Tumor Factors Associated with High Risk of Recurrence in Sentinel Node-Negative Melanoma Patients.

BACKGROUND: Since its introduction, the sentinel lymph node biopsy (SLNB) has become the standard staging procedure in clinical node-negative melanoma patients. A negative SLNB, however, does not guarantee a recurrence-free survival. Insight into metastatic patterns and risk factors for recurrence in SLNB negative melanoma patients can provide patient tailored guidelines. METHODS: Data concerning melanoma patients who underwent SLNB between 1996 and 2015 in a single center were prospectively collected. Cox regression analyses were used to determine variables associated with overall recurrence and distant first site of recurrence in SLNB-negative patients. RESULTS: In 668 patients, SLNBs were performed between 1996 and 2015. Of these patients, 50.4 % were male and 49.6 % female with a median age of 55.2 (range 5.7-88.8) years. Median Breslow thickness was 2.2 (range 0.3-20) mm. The SLNB was positive in 27.8 % of patients. Recurrence rates were 53.2 % in SLNB-positive and 17.9 % in SLNB-negative patients (p < 0.001). For SLNB-negative patients, the site of first recurrence was distant in 58.5 %. Melanoma located in the head and neck region (hazard ratio 4.88, p = 0.003) and increasing Breslow thickness (hazard ratio 1.15, p = 0.013) were predictive for distant first site of recurrence in SLNB-negative patients. SLNB-negative patients with a nodular melanoma and ulceration had a recurrence rate of 43.1 %; the site of recurrence was distant in 64 % of these patients. CONCLUSIONS: The recurrence rates of SLNB-negative nodular ulcerative melanoma patients approach those of SLNB-positive patients. Stringent follow-up is recommended in this subset of patients.

Factors influencing the use of sentinel lymph node biopsy in the Netherlands.

BACKGROUND: In the US, whether a sentinel lymph node biopsy (SLNB) is performed depends on tumor and patient factors, including socioeconomic status (SES) and type of health care insurance. We analyzed which patient and tumor characteristics influenced the use of SLNB in a country where every patient has equal access to healthcare. METHODS: Patients diagnosed with a cutaneous invasive melanoma of ≥1 mm between 2004 and 2011 and living in the northeastern part of the Netherlands were selected from the Netherlands Cancer Registry. Regression analysis was performed to assess the association of patient and tumor characteristics and SLNB use. RESULTS: SLNB was performed in 42 % of the 2,413 included patients. The frequency of performing SLNB increased between 2004 and 2011 from 24 to 55 % (p < 0.001). Patients were less likely to undergo SLNB if they had a melanoma located in the head and neck area (p < 0.001), when they were over 55 years (p = 0.001), and if they had a low SES (p = 0.03). SLNB use was more likely when the diagnosis of melanoma was made in the university hospital (p = 0.045) or when the Breslow thickness was 2.01-4.0 mm (p = 0.03). CONCLUSIONS: The use of SLNB has increased significantly between 2004 and 2011. However, in 2011 it was still performed in only 55 % of the Dutch patients with a melanoma ≥1 mm. In patients with head and neck melanoma, older patients, and patients with low SES, SLNB was less frequently performed. Patients with T3 melanomas and a diagnosis made in the university hospital more often had an SLNB performed.

Laparoscopic cholecystectomy in acute cholecystitis: C-reactive protein level combined with age predicts conversion.

INTRODUCTION: The aim was to enable prediction of risk for conversion in early laparoscopic cholecystectomy for acute cholecystitis. METHODS: Multivariate analysis and receiver operating characteristic curve analysis were used to define independent predictors for conversion and optimal cutoffs. Using those, a scoring system was created to predict conversion. RESULTS: In 261 patients, conversion to open cholecystectomy was necessary in 62 cases (24%). Multivariate analysis revealed age and C-reactive protein (CRP) level to be independent predictors for conversion (odds ratio 1.02; P=0.02 and odds ratio 1.01; P<0.001). Using cutoffs obtained by receiver operating characteristic curve analysis resulted in an useful scoring system to predict conversion risk (age>65 y=1+CRP value>165 mg/L=1): score 0=12%, 1=29%, 2=67% (P<0.001). CONCLUSIONS: Higher age and elevated CRP level are independent predictors for conversion. Surgery for acute cholecystitis in patients with age >65 years and/or CRP level >165 mg/L should be considered as high risk for conversion.

Reoperation after colorectal surgery is an independent predictor of the 1-year mortality rate.

BACKGROUND: Comparative evaluation of surgical quality among hospitals must improve outcome and efficiency, and reduce medical costs. Reoperation after colorectal surgery is a consequence of surgical complications and therefore considered a quality-of-care indicator. With respect to the mortality rate, the 1-year mortality may be a more meaningful figure than in-hospital mortality, because it also reflects the impact of surgical complications beyond discharge. OBJECTIVE: The aim of our study was to evaluate the 1-year mortality after colorectal surgery and to identify predicting factors. DESIGN: This study was a retrospective analysis from our colorectal surgery database. PATIENTS: All patients who underwent elective colorectal surgery from 2005 to 2008 were included. MAIN OUTCOME MEASURES: Both univariate and multivariate analysis were performed to identify predicting factors. The following variables were analyzed: age, operative risk according to the ASA class, Charlson-Age Comorbidity Index, indication for and type of resection, primary anastomosis, tumor staging, anastomotic leakage, and reoperation. RESULTS: For 743 consecutive patients, the 1-year mortality rate was 6.9%. Patients were operated on mainly because of colorectal cancer (n = 537; 72%). The rate of reoperation and in-hospital mortality was 12.8% and 2.4%. Univariate survival analysis demonstrated that ASA class, age, Charlson-Age Comorbidity Index, reoperation, and stage of disease were independent predictors of 1-year mortality. Multivariate analysis showed that ASA class (P = .020; HR 1.69), age (P = .015; HR 2.08) and reoperation (P = .001; HR 2.72) are directly correlated with 1-year mortality. LIMITATIONS: Both patients with benign diseases and colorectal cancer are included. Furthermore, no clear guidelines on whether to perform a reoperation were available. CONCLUSION: One-year mortality after colorectal surgery is independently predicted by ASA class, age, and reoperation. Our results underline the value of the 1-year mortality rate and the reoperation rate as parameters for quality assessment in colorectal surgery.