Oncological outcome after MRI-based selection for neoadjuvant chemoradiotherapy in the OCUM Rectal Cancer Trial.

BACKGROUND: It is not clear whether all patients with rectal cancer need chemoradiotherapy. A restrictive use of neoadjuvant chemoradiotherapy (nCRT) based on MRI findings for rectal cancer was investigated in this study. METHODS: This prospective multicentre observational study included patients with stage cT2-4 rectal cancer, with any cN and cM0 status. Carcinomas in the middle and lower third that were 1 mm or less from the mesorectal fascia, all cT4 tumours, and all cT3 tumours of the lower third were classified as high risk, and these patients received nCRT followed by total mesorectal excision (TME). All other carcinomas with a minimum distance of more than 1 mm from the mesorectal fascia and those in the upper third were classified as low risk; these patients underwent TME alone (no nCRT). Patients were followed for at least 3 years. Outcomes were the rates of local recurrence, distant metastasis and survival. RESULTS: Among 545 patients included, 428 were treated according to the study protocol: 254 (59·3 per cent) had TME alone and 174 (40·7 per cent) received nCRT and TME. Median follow-up was 60 months. The 3- and 5-year local recurrence rates were 1·3 and 2·7 per cent respectively, with no differences between the two treatment protocols. Patients with disease requiring nCRT had higher 3- and 5-year rates of distant metastasis (17·3 and 24·9 per cent respectively versus 8·9 and 14·4 per cent in patients who had TME alone; P = 0·005) and worse disease-free survival compared with that in patients who did not need nCRT (3- and 5-year rates 76·7 and 66·7 per cent, versus 84·9 and 76·0 per cent in the TME-alone group; P = 0·016). CONCLUSION: Restriction of nCRT to high-risk patients achieved good results.

[Quality of Mesorectal Excision ("Plane of Surgery") - Which Quality Targets are Adequate?]. / Qualität der Mesorektumexzision ("plane of surgery") - Welche Qualitätsziele sind angemessen?

Today, the examination of rectal cancer specimens includes the obligate macroscopic assessment of the quality of mesorectal excision by the pathologist reporting the plane of surgery. The frequency of operations in the muscularis propria plane of surgery (earlier described as incomplete mesorectal excision) is essential. The quality of mesorectal excision is important for the prognosis, especially as local recurrences are observed more frequently after operations in the muscularis propria plane of surgery. For the definition of quality targets, data of 13 studies published between 2006 and 2012, each with more than 100 patients and adequate specialisation and experience of the surgeons (5413 patients), data of the prospective multicentric observation study "Quality Assurance - Rectal Cancer" (at the Institute for Quality Assurance in Operative Medicine at the Otto-von-Guericke University at Magdeburg) from 2005 to 2010 (8044 patients) and data of the Department of Surgery, University Hospital Erlangen, from 1998 to 2011 (991 patients) were analysed. The total incidence of operations in the muscularis propria plane of surgery was 5.0 % (721/14 448). Even with adequate specialisation and experience of the surgeon, the frequency of operations in the muscularis propria plane of surgery is higher in abdominoperineal excisions than in sphincter-preserving surgery (8.4 vs. 2.8 %, p < 0.001). Thus, the quality target for the frequency of operations in the muscularis propria plane should be defined as < 5 % for sphincter-preserving procedures and as < 10 % for abdominoperineal excisions.

[Rectal cancer surgery in Germany - a 10-year-analysis based on the data of the "Institute of Quality Assurance in Operative Medicine" at the Otto-von-Guericke University Magdeburg]. / Rektumkarzinomchirurgie in Deutschland - eine 10-Jahres-Übersicht auf der Grundlage der Daten des AN-Instituts für Qualitätssicherung in der operativen Medizin gGmbH an der Otto-von-Guericke-Universität Magdeburg.

BACKGROUND: The treatment of rectal cancer has undergone pronounced changes during the last two decades. There has been a significant improvement in local tumour control due to consequent use of neo-adjuvant therapy and total mesorectal excision in cases of distal rectal cancer. The presented analysis examines the realisation of the multimodal therapy for rectal cancer under the conditions of routine patient-centred care over a period of ten years. METHOD: The data acquired in the prospective multicentre observational study "Quality Assurance - Rectal Cancer" from the years 2000 to 2010 were analysed. N = 33,724 patients were documented. The resection rate was 95.2 %. The rate of curative resection was 84.2 %. RESULTS: No change was detected in perioperative total morbidity and lethality during the course of the study. The percentage of patients with neo-adjuvant treatment and curative resection rose from 5.6 % (2000) to 40.5 % (2012). The rate of performed TME in distal rectal cancer rose from 75.2 % (2000) to 95.3 % (2012). For patients who underwent curative resection in the years 2000/2001 the 5-year local recurrence rate was 11.7 %, while it was found to be 4.6 % for patients who were thus treated in the years 2005/2006 (p < 0.001). There was no improvement of total survival. CONCLUSION: While an increase in the use of neo-adjuvant treatment for rectal cancer and the establishment of TME in routine patient-centred care have led to a significant improvement in local tumour control with a constant total morbidity and lethality, there is no detectable influence on the patients' total survival.

[Surgical treatment of carcinomas of the oesophagogastric junction - results achieved in multicentre studies]. / Multizentrische Ergebnisse der chirurgischen Therapie der Karzinome des ösophagogastralen Übergangs.

BACKGROUND: Adenocarcinomas of the oesophagogastric junction are increasingly being considered as a separated tumour entity. The prognosis is rather poorer compared with that for distal gastric cancer. Data from a multicentre study as part of research on clinical care aim to reflect the current situation in surgical treatment after inauguration of neoadjuvant modalities. PATIENTS AND METHOD: As part of the ongoing prospective multicentre observational study QCGC 2 (German Gastric Cancer Study 2), 544 adenocarcinomas of the oesophagogastric junction (AEG 1-3) were registered from 01/01/2007 to 12/31/2009. RESULTS: Patients underwent surgical intervention in 108 (76.6 %) of the 141 surgical departments which provided data to the study. In 391 patients (82.5 %), R0 resection was achieved. Almost 60 % of the carcinomas of the oesophagogastric junction were approached in departments with no more than 10 of these tumour lesions through the whole study period (3 years). Endoscopic ultrasonography was performed in 283 cases (53 %); the rate of neoadjuvant treatment was 34.4 % (n = 187). Intraoperative fresh frozen section was only included in intraoperative decision-making in 242 patients (60.8 %). In the revealed heterogeneous spectrum of surgical interventions, a limited number of transthoracic approaches (20 %) and a mediastinal lymphadenectomy rate of only 47 % were found. Hospital lethality was 6.6 %. In the adenocarcinomas of the oesophagogastric junction, a significantly lower median survival (25 months) compared with distal gastric cancer (38 months) was observed depending on the tumour stage. In addition, 5-year survival rate of AEG patients (33.1 %) was distinctly lower than for patients with distal gastric cancer (41.4 %). There was no significantly better survival by neoadjuvant treatment in the group of investigated patients. CONCLUSION: The results in the treatment of carcinomas of the oesophagogastric junction in the multicentre setting including surgical departments of each profile and region even after introduction of multimodal therapeutic concepts are not satisfying. In particular, modern diagnostic and surgical strategies need to be widely used or their percentage has to be increased. In this context, centralisation of the surgical care of this specific tumour entity appears reasonable.

[Quality indicators of diagnosis and therapy in MRI-based neoadjuvant radiochemotherapy for rectal cancer - interim analysis of a Prospective Multicentre Observational Study (OCUM)]. / Qualitätsindikaktoren der Diagnose und Therapie bei MRT-basierter neoadjuvanter Radiochemotherapie des Rektumkarzinoms - Interimsanalyse einer prospektiven, multizentrischen Beobachtungsstudie (OCUM).

BACKGROUND: The interim analysis of a prospective multicentre observational study of selective neoadjuvant chemoradiotherapy (OCUM) in patients with rectal cancer should evaluate the quality of diagnosis and therapy as a prerequisite for continuation of the study. PATIENTS AND METHODS: 230 patients with the clinical stage cT2 - 4, each cN, M0 with radical tumour resection were enrolled until now. The values of 13 quality indicators were compared with the target values formulated by the workflow of the Working Group rectal cancer II and the German Cancer Society and were also compared with the results of the certified bowel centres of Germany 2010. RESULTS: The target values were fulfilled to a high degree regardless of caseload. 83 % of parameters have been fully achieved and 14 % nearly achieved. In primary surgery the proportion of patients with 12 or more histologically examined lymph nodes was 99.2 %, after neoadjuvant chemoradiotherapy 90 %. A R0 resection was performed in 98.3 % and a resection of TME in muscularis propria plane only in 2.2 %. The rate of positive circumferential resection margins (pCRM + ) was 5.7 % only. CONCLUSIONS: The high quality of rectal surgery justifies the concept and the continuation of the study.

Factors influencing the quality of total mesorectal excision.

BACKGROUND: Total mesorectal excision (TME) has become the standard of care for rectal cancer. Incomplete TME may lead to local recurrence. METHODS: Data from the multicentre observational German Quality Assurance in Rectal Cancer Trial were used. Patients undergoing low anterior resection for rectal cancer between 1 January 2005 and 31 December 2009 were included. Multivariable analysis using a stepwise logistic regression model was performed to identify predictors of suboptimal TME. RESULTS: From a total of 6179 patients, complete data sets for 4606 patients were available for analysis. Pathological tumour category higher than T2 (pT3 versus pT1/2: odds ratio (OR) 1.22, 95 per cent confidence interval 1.01 to 1.47), tumour distance from the anal verge less than 8 cm (OR 1.27, 1.05 to 1.53), advanced age (65-80 years: OR 1.25, 1.03 to 1.52; over 80 years: OR 1.60, 1.15 to 2.22), presence of intraoperative complications (OR 1.63, 1.15 to 2.30), monopolar dissection technique (OR 1.43, 1.14 to 1.79) and low case volume (fewer than 20 procedures per year) of the operating surgeon (OR 1.20, 1.06 to 1.36) were independently associated with moderate or poor TME quality. CONCLUSION: TME quality was influenced by patient- and treatment-related factors.

Endorectal ultrasound in rectal carcinoma--do the literature results really correspond to the realities of routine clinical care?

BACKGROUND AND STUDY AIMS: This multicenter, prospective, country-wide quality-assurance study at more than 300 hospitals in Germany was designed to characterize and analyze the diagnostic accuracy of rectal endoscopic ultrasound (EUS) in the routine clinical staging of rectal carcinoma (depth of tumor infiltration). PATIENTS AND METHODS: Patients were surveyed between 1 January 2000 and 31 December 2008. Those who received neoadjuvant therapy after EUS were excluded. The correspondence between the EUS assessment of tumor depth (uT) and that determined by histology (pT) was calculated, and the influence of hospital volume upon the sensitivity, specificity, and positive and negative predictive values was investigated. RESULTS: At 384 hospitals providing care at all levels, 29 206 patients were included; of the 27 458 treated by surgical resection, EUS was performed for 12 235 (44.6 %). Of these, 7096 did not receive neoadjuvant radiochemotherapy, allowing a uT-pT comparison. The uT-pT correspondence was 64.7 % (95 % confidence interval [CI] 63.6 % - 65.8 %); the frequency of understaging was 18 % (95 %CI 17.1 % - 18.9 %) and that of overstaging was 17.3 % (95 %CI 16.4 % - 18.2 %). The kappa coefficient was greatest in the category T1 (κ = 0.591). For T3 tumors κ was 0.468. The poorest correspondence was found for T2 and T4 tumors (κ = 0.367 and 0.321, respectively). A breakdown by hospital volume showed that the uT-pT correspondence was 63.2 % (95 %CI 61.5 % - 64.9 %) for hospitals undertaking ≤ 10 EUS/year, 64.6 % (95 %CI 62.9 % - 66.2 %) for doing 11 - 30 EUS/year, and 73.1 % (95 %CI 69.4 % - 76.5 %) for those hospitals performing > 30 EUS/year. CONCLUSIONS: In clinical routine, the diagnostic accuracy of transrectal ultrasound in staging rectal carcinoma does not attain the very good results reported in the literature. Only in the hands of diagnosticians with a large case volume of rectal carcinoma patients can EUS lead to therapy-relevant decisions.

Low-volume centre vs high-volume: the role of a quality assurance programme in colon cancer surgery.

AIM: The study aimed to determine whether hospitals within a quality assurance programme have outcomes of colon cancer surgery related to volume. METHOD: Data were used from an observational study to determine whether outcomes of colon cancer surgery are related to hospital volume. Hospitals were divided into three groups (low, medium and high) based on annual caseload. Cancer staging, resected lymph nodes, perioperative complications and follow up were monitored. Between 2000 and 2004, 345 hospitals entered 31,261 patients into the study: 202 hospitals (group I) were classified as low volume (<30 operations; 7760 patients; 24.8%), 111 (group II) as medium volume (30-60; 14,008 patients; 44.8%) and 32 (groups III) as high volume (>60; 9493 patients; 30.4%). RESULTS: High-volume centres treated more patients in UICC stages 0, I and IV, whereas low-volume centres treated more in stages II and III (P<0.001). There was no significant difference for intra-operative complications and anastomotic leakage. The difference in 30-day mortality between the low and high-volume groups was 0.8% (P=0.023).Local recurrence at 5 years was highest in the medium group. Overall survival was highest in the high-volume group; however, the difference was only significant between the medium and high-volume groups. For the low and high-volume groups, there was no significant difference in the 5-year overall survival rates. CONCLUSION: A definitive statement on outcome differences between low-volume and high-volume centres participating in a quality assurance programme cannot be made because of the heterogeneity of results and levels of significance. Studies on volume-outcome effects should be regarded critically.

Palliative stoma creation: comparison of laparoscopic vs conventional procedures.

BACKGROUND: The creation of a stoma is an established therapeutic concept for the palliation of non-resectable rectal carcinomas and advanced tumours infiltrating the pelvis. MATERIALS AND METHODS: In two prospective country-wide multicentre studies, each conducted over a similar period of time, the peri-operative course and postoperative short-term outcomes of laparoscopic vs laparotomy-based stoma construction were compared. RESULTS: A total of 90 patients underwent palliative laparoscopic construction; 550 patients received a stoma via a laparotomy. The intra-operative complication rate was lower after open surgery than after laparoscopic surgery (2.7 vs 5.6%; p = 0.15), although the difference was not significant. With regard to general (30.9 vs 15.6%; p = 0.003) and also specific postoperative complications (13.8 vs 5.6%; p = 0.029), however, a significant advantage of the laparoscopic approach was seen. Furthermore, mortality in the laparoscopic group was also significantly lower (4.4 vs 14.0%; p = 0.011). CONCLUSION: Palliative stoma done via laparoscopy had significantly better outcomes in terms of postoperative morbidity and mortality in comparison with the open surgical procedure.

[Investigations on in-hospital mortality in pancreatic surgery : Results of a multicenter observational study]. / Untersuchungen zur Hospitalletalität in der Pankreaschirurgie : Ergebnisse einer multizentrischen Beobachtungsstudie.

BACKGROUND: The rate of hospital mortality (in-hospital mortality) after complex pancreatic resections cannot be used as a decision-making criterion with no further analysis and specification. Such analysis has to provide a risk-adjusted benchmarking including a continuous evaluation taking into account the frequency of a surgical procedure and its competent perioperative management. MATERIAL AND METHODS: As part of the Prospective Evaluation study Elective Pancreatic surgery (PEEP), overall 2003 patients were enrolled over a 3-year time period from 01 January 2006 to 12 December 2008, who underwent elective pancreatic surgery in 27 surgical departments. Included in the study were only hospitals which perform pancreatic resections. In addition to the analysis of the current situation of the operative treatment of pancreatic diseases, the complex aspects of the in-hospital mortality as a main outcome parameter were investigated. RESULTS: Out of all enrolled patients (n = 2003), 75 patients (3.7%) died during the hospital stay. In the group of 1045 patients with partial pancreaticoduodenectomy (PD), 43 patients did not survive the hospital stay (4.1%). Similarly, such low in-hospital mortality rates were observed after total pancreatoduodenectomy (3.8%) and after left-sided resection of the pancreas (1.9%). With respect to a univariate risk stratification, advanced age and an American Society of Anaesthesiologists (ASA) score of 3 and 4 had a significant impact on in-hospital mortality. Multivariate regression analysis within the PD group revealed an increased need for blood transfusions and a delay in oral feeding as factors closely associated with specific complications with a significant impact on in-hospital mortality. Significant differences in the in-hospital mortality rates were found when comparing hospital volume groups, such as 10-20 vs. >20 cases/year for the 831 Kausch-Whipple procedures for adenocarcinoma and chronic pancreatitis. DISCUSSION: An adequate in-hospital mortality rate in the continuous benchmarking represents an acceptable quality level of structural and therapeutic predictions in pancreatic resections. The participation of surgical departments with complex oncosurgical interventions in clinical multicenter observational studies as a contribution to research on surgical care appears reasonable and recommendable since the results of such studies can provide a contribution to decision-making processes in daily surgical practice.