Summary Background Previous results of the EORTC intergroup trial 40983 showed that perioperative chemotherapy with FOLFOX4 (folinic acid, fluorouracil, and oxaliplatin) increases progression-free ...survival (PFS) compared with surgery alone for patients with initially resectable liver metastases from colorectal cancer. Here we present overall survival data after long-term follow-up. Methods This randomised, controlled, parallel-group, phase 3 study recruited patients from 78 hospitals across Europe, Australia, and Hong Kong. Eligible patients aged 18–80 years who had histologically proven colorectal cancer and up to four liver metastases were randomly assigned (1:1) to either perioperative FOLFOX4 or surgery alone. Perioperative FOLFOX4 consisted of six 14-day cycles of oxaliplatin 85mg/m2 , folinic acid 200 mg/m2 (DL form) or 100 mg/m2 (L form) on days 1–2 plus bolus, and fluorouracil 400 mg/m2 (bolus) and 600 mg/m2 (continuous 22 h infusion), before and after surgery. Patients were centrally randomised by minimisation, adjusting for centre and risk score and previous adjuvant chemotherapy to primary surgery for colorectal cancer, and the trial was open label. Analysis of overall survival was by intention to treat in all randomly assigned patients. This trial is registered with ClinicalTrials.gov , number NCT00006479. Findings Between Oct 10, 2000, and July 5, 2004, 364 patients were randomly assigned to a treatment group (182 patients in each group, of which 171 per group were eligible and 152 per group underwent resection). At a median follow-up of 8·5 years (IQR 7·6–9·5), 107 (59%) patients in the perioperative chemotherapy group had died versus 114 (63%) in the surgery-only group (HR 0·88, 95% CI 0·68–1·14; p=0·34). In all randomly assigned patients, median overall survival was 61·3 months (95% CI 51·0–83·4) in the perioperative chemotherapy group and 54·3 months (41·9–79·4) in the surgery alone group. 5-year overall survival was 51·2% (95% CI 43·6–58·3) in the perioperative chemotherapy group versus 47·8% (40·3–55·0) in the surgery-only group. Two patients in the perioperative chemotherapy group and three in the surgery-only group died from complications of protocol surgery, and one patient in the perioperative chemotherapy group died possibly as a result of toxicity of protocol treatment. Interpretation We found no difference in overall survival with the addition of perioperative chemotherapy with FOLFOX4 compared with surgery alone for patients with resectable liver metastases from colorectal cancer. However, the previously observed benefit in PFS means that perioperative chemotherapy with FOLFOX4 should remain the reference treatment for this population of patients. Funding Norwegian and Swedish Cancer Societies, Cancer Research UK, Ligue Nationale Contre Cancer, US National Cancer Institute, Sanofi-Aventis.
BDI is the most common serious complication of laparoscopic cholecystectomy. To address this problem, a multi-society consensus conference was held to develop evidenced-based recommendations for safe ...cholecystectomy and prevention of BDI.
Literature reviews were conducted for 18 key questions across 6 broad topics around cholecystectomy directed by a steering group and subject experts from 5 surgical societies (Society of Gastrointestinal and Endoscopic Surgeons, Americas Hepato-Pancreato-Biliary Association, International Hepato-Pancreato-Biliary Association, Society for Surgery of the Alimentary Tract, and European Association for Endoscopic Surgery). Evidence-based recommendations were formulated using the grading of recommendations assessment, development, and evaluation methodology. When evidence-based recommendations could not be made, expert opinion was documented. A number of recommendations for future research were also documented. Recommendations were presented at a consensus meeting in October 2018 and were voted on by an international panel of 25 experts with greater than 80% agreement considered consensus.
Consensus was reached on 17 of 18 questions by the guideline development group and expert panel with high concordance from audience participation. Most recommendations were conditional due to low certainty of evidence. Strong recommendations were made for (1) use of intraoperative biliary imaging for uncertainty of anatomy or suspicion of biliary injury; and (2) referral of patients with confirmed or suspected BDI to an experienced surgeon/multispecialty hepatobiliary team.
These consensus recommendations should provide guidance to surgeons, training programs, hospitals, and professional societies for strategies that have the potential to reduce BDIs and positively impact patient outcomes. Development of clinical and educational research initiatives based on these recommendations may drive further improvement in the quality of surgical care for patients undergoing cholecystectomy.
Abstract Objectives Liver metastasis from a neuroendocrine tumour (NET) represents a significant clinical entity. A multidisciplinary group of experts was convened to develop state-of-the-art ...recommendations for its management. Methods Peer-reviewed published reports on intra-arterial therapies for NET hepatic metastases were reviewed and the findings presented to a jury of peers. The therapies reviewed included transarterial embolization (TAE), transarterial chemoembolization (TACE) and radioembolization (RE). Two systems were used to evaluate the level of evidence in each publication: (i) the US National Cancer Institute (NCI) system, and (ii) the GRADE system. Results Eighteen publications were reviewed. These comprised 11 reports on TAE or TACE and seven on RE. Four questions posed to the panel were answered and recommendations offered. Conclusions Studies of moderate quality support the use of TAE, TACE and RE in hepatic metastases of NETs. The quality and strength of the reports available do not allow any modality to be determined as superior in terms of imaging response, symptomatic response or impact on survival. Radioembolization may have advantages over TAE and TACE because it causes fewer side-effects and requires fewer treatments. Based on current European Neuroendocrine Tumor Society (ENETS) Consensus Guidelines, RE can be substituted for TAE or TACE in patients with either liver-only disease or those with limited extrahepatic metastases.
Summary Background Surgical resection alone is regarded as the standard of care for patients with liver metastases from colorectal cancer, but relapse is common. We assessed the combination of ...perioperative chemotherapy and surgery compared with surgery alone for patients with initially resectable liver metastases from colorectal cancer. Methods This parallel-group study reports the trial's final data for progression-free survival for a protocol unspecified interim time-point, while overall survival is still being monitored. 364 patients with histologically proven colorectal cancer and up to four liver metastases were randomly assigned to either six cycles of FOLFOX4 before and six cycles after surgery or to surgery alone (182 in perioperative chemotherapy group vs 182 in surgery group). Patients were centrally randomised by minimisation, adjusting for centre and risk score. The primary objective was to detect a hazard ratio (HR) of 0·71 or less for progression-free survival. Primary analysis was by intention to treat. Analyses were repeated for all eligible (171 vs 171) and resected patients (151 vs 152). This trial is registered with ClinicalTrials.gov , number NCT00006479. Findings In the perioperative chemotherapy group, 151 (83%) patients were resected after a median of six (range 1–6) preoperative cycles and 115 (63%) patients received a median six (1–8) postoperative cycles. 152 (84%) patients were resected in the surgery group. The absolute increase in rate of progression-free survival at 3 years was 7·3% (from 28·1% 95·66% CI 21·3–35·5 to 35·4% 28·1–42·7; HR 0·79 0·62–1·02; p=0·058) in randomised patients; 8·1% (from 28·1% 21·2–36·6 to 36·2% 28·7–43·8; HR 0·77 0·60–1·00; p=0·041) in eligible patients; and 9·2% (from 33·2% 25·3–41·2 to 42·4% 34·0–50·5; HR 0·73 0·55–0·97; p=0·025) in patients undergoing resection. 139 patients died (64 in perioperative chemotherapy group vs 75 in surgery group). Reversible postoperative complications occurred more often after chemotherapy than after surgery (40/159 25% vs 27/170 16%; p=0·04). After surgery we recorded two deaths in the surgery alone group and one in the perioperative chemotherapy group. Interpretation Perioperative chemotherapy with FOLFOX4 is compatible with major liver surgery and reduces the risk of events of progression-free survival in eligible and resected patients. Funding Swedish Cancer Society, Cancer Research UK, Ligue Nationale Contre le Cancer, US National Cancer Institute, Sanofi-Aventis.
Clinical update on management of pancreatic trauma Søreide, Kjetil; Weiser, Thomas G.; Parks, Rowan W.
HPB (Oxford, England),
December 2018, 2018-Dec, 2018-12-00, 20181201, Letnik:
20, Številka:
12
Journal Article
Recenzirano
Odprti dostop
Pancreatic injury is rare and optimal diagnosis and management is still debated. The aim of this study was to review the existing data and consensus on management of pancreatic trauma.
Systematic ...literature review until May 2018.
Pancreas injury is reported in 0.2–0.3% of all trauma patients. Severity is scored by the organ injury scale (OIS), with new scores including physiology needing validation. Diagnosis is difficult, clinical signs subtle, and imaging by ultrasound (US) and computed tomography (CT) non-specific with <60% sensitivity for pancreatic duct injury. MRCP and ERCP have superior sensitivity (90–100%) for detecting ductal disruption. Early ERCP with stent is a feasible approach for initial management of all branch-duct and most main-duct injuries. Distal pancreatectomy (±splenectomy) may be required for a transected gland distal to the major vessels. Early peripancreatic fluid collections are common in ductal injuries and one-fifth may develop pseudocysts, of which two-thirds can be managed conservatively. Non-operative management has a high success rate (50–75%), even in high-grade injuries, but associated with morbidity. Mortality is related to associated injuries.
Pancreatic injuries are rare and can often be managed non-operatively, supported by percutaneous drainage and ductal stenting. Distal pancreatectomy is the most common operative procedure.
Background
Protocols for enhanced recovery provide comprehensive and evidence-based guidelines for best perioperative care. Protocol implementation may reduce complication rates and enhance ...functional recovery and, as a result of this, also reduce length-of-stay in hospital. There is no comprehensive framework available for pancreaticoduodenectomy.
Methods
An international working group constructed within the Enhanced Recovery After Surgery (ERAS
®
) Society constructed a comprehensive and evidence-based framework for best perioperative care for pancreaticoduodenectomy patients. Data were retrieved from standard databases and personal archives. Evidence and recommendations were classified according to the GRADE system and reached through consensus in the group. The quality of evidence was rated “high”, “moderate”, “low” or “very low”. Recommendations were graded as “strong” or “weak”.
Results
Comprehensive guidelines are presented. Available evidence is summarised and recommendations given for 27 care items. The quality of evidence varies substantially and further research is needed for many issues to improve the strength of evidence and grade of recommendations.
Conclusions
The present evidence-based guidelines provide the necessary platform upon which to base a unified protocol for perioperative care for pancreaticoduodenectomy. A unified protocol allows for comparison between centres and across national borders. It facilitates multi-institutional prospective cohort registries and adequately powered randomised trials.
Background Many studies have evaluated serum levels of procalcitonin (PCT) as a predictor in the development of severe acute pancreatitis (SAP) and infected pancreatic necrosis (IPN). This study ...assesses the value of PCT as a marker of development of SAP and IPN. Methods Medline, Web of Science, the Cochrane clinical trials register, and international conference proceedings were searched systematically for prospective studies, which evaluated the usefulness of PCT as a marker of SAP and IPN. The sensitivity, specificity, and diagnostic odds ratios (DORs) were calculated for each study, and the study quality and heterogeneity among the studies were evaluated. Results Twenty-four of 59 studies identified were included in data extraction. The sensitivity and specificity of PCT for development of SAP were 0.72 and 0.86, respectively (area under the curve AUC = 0.87; DOR = 14.9; 95% confidence interval CI = 5.6–39.8), albeit with a significant degree of heterogeneity (Q = 28.56, P < .01). The sensitivity and specificity of PCT for prediction of infected pancreatic necrosis were 0.80 and 0.91 (AUC = 0.91; DOR = 28.3; 95% CI = 13.8–58.3) with no significant heterogeneity (Q = 7.83, P = .18). No significant heterogeneity was observed among the studies when only higher quality studies (AUC = 0.91; DOR = 30.7; 95% CI = 10.7–87.8) or studies that used a cutoff PCT level >0.5 ng/mL (AUC = 0.88, 32.8; 95% CI = 10.1–106.6) were included. Conclusion Serum measurements of PCT may be valuable in predicting the severity of acute pancreatitis and the risk of developing infected pancreatic necrosis.
Summary Background & aims Protocols for enhanced recovery provide comprehensive and evidence-based guidelines for best perioperative care. Protocol implementation may reduce complication rates and ...enhance functional recovery and, as a result of this, also reduce length-of-stay in hospital. There is no comprehensive framework available for pancreaticoduodenectomy. Methods An international working group constructed within the Enhanced Recovery After Surgery (ERAS® ) Society constructed a comprehensive and evidence-based framework for best perioperative care for pancreaticoduodenectomy patients. Data were retrieved from standard databases and personal archives. Evidence and recommendations were classified according to the GRADE system and reached through consensus in the group. The quality of evidence was rated “high”, “moderate”, “low” or “very low”. Recommendations were graded as “strong” or “weak”. Results Comprehensive guidelines are presented. Available evidence is summarised and recommendations given for 27 care items. The quality of evidence varies substantially and further research is needed for many issues to improve the strength of evidence and grade of recommendations. Conclusions The present evidence-based guidelines provide the necessary platform upon which to base a unified protocol for perioperative care for pancreaticoduodenectomy. A unified protocol allows for comparison between centres and across national borders. It facilitates multi-institutional prospective cohort registries and adequately powered randomised trials.
PDF
