Algorithm-based care versus usual care for the early recognition and management of complications after pancreatic resection in the Netherlands: an open-label, nationwide, stepped-wedge cluster-randomised trial.

BACKGROUND: Early recognition and management of postoperative complications, before they become clinically relevant, can improve postoperative outcomes for patients, especially for high-risk procedures such as pancreatic resection. METHODS: We did an open-label, nationwide, stepped-wedge cluster-randomised trial that included all patients having pancreatic resection during a 22-month period in the Netherlands. In this trial design, all 17 centres that did pancreatic surgery were randomly allocated for the timing of the crossover from usual care (the control group) to treatment given in accordance with a multimodal, multidisciplinary algorithm for the early recognition and minimally invasive management of postoperative complications (the intervention group). Randomisation was done by an independent statistician using a computer-generated scheme, stratified to ensure that low-medium-volume centres alternated with high-volume centres. Patients and investigators were not masked to treatment. A smartphone app was designed that incorporated the algorithm and included the daily evaluation of clinical and biochemical markers. The algorithm determined when to do abdominal CT, radiological drainage, start antibiotic treatment, and remove abdominal drains. After crossover, clinicians were trained in how to use the algorithm during a 4-week wash-in period; analyses comparing outcomes between the control group and the intervention group included all patients other than those having pancreatic resection during this wash-in period. The primary outcome was a composite of bleeding that required invasive intervention, organ failure, and 90-day mortality, and was assessed by a masked adjudication committee. This trial was registered in the Netherlands Trial Register, NL6671. FINDINGS: From Jan 8, 2018, to Nov 9, 2019, all 1805 patients who had pancreatic resection in the Netherlands were eligible for and included in this study. 57 patients who underwent resection during the wash-in phase were excluded from the primary analysis. 1748 patients (885 receiving usual care and 863 receiving algorithm-centred care) were included. The primary outcome occurred in fewer patients in the algorithm-centred care group than in the usual care group (73 [8%] of 863 patients vs 124 [14%] of 885 patients; adjusted risk ratio [RR] 0·48, 95% CI 0·38-0·61; p<0·0001). Among patients treated according to the algorithm, compared with patients who received usual care there was a decrease in bleeding that required intervention (47 [5%] patients vs 51 [6%] patients; RR 0·65, 0·42-0·99; p=0·046), organ failure (39 [5%] patients vs 92 [10%] patients; 0·35, 0·20-0·60; p=0·0001), and 90-day mortality (23 [3%] patients vs 44 [5%] patients; 0·42, 0·19-0·92; p=0·029). INTERPRETATION: The algorithm for the early recognition and minimally invasive management of complications after pancreatic resection considerably improved clinical outcomes compared with usual care. This difference included an approximate 50% reduction in mortality at 90 days. FUNDING: The Dutch Cancer Society and UMC Utrecht.

Systematic review on the use of matrix-bound sealants in pancreatic resection.

BACKGROUND: Pancreatic fistula is a potentially life-threatening complication after a pancreatic resection. The aim of this systematic review was to evaluate the role of matrix-bound sealants after a pancreatic resection in terms of preventing or ameliorating the course of a post-operative pancreatic fistula. METHODS: A systematic search was performed in the literature from May 2005 to April 2015. Included were clinical studies using matrix-bound sealants after a pancreatic resection, reporting a post-operative pancreatic fistula (POPF) according to the International Study Group on Pancreatic Fistula classification, in which grade B and C fistulae were considered clinically relevant. RESULTS: Two were studies on patients undergoing pancreatoduodenectomy (sealants n = 67, controls n = 27) and four studies on a distal pancreatectomy (sealants n = 258, controls n = 178). After a pancreatoduodenectomy, 13% of patients treated with sealants versus 11% of patients without sealants developed a POPF (P = 0.76), of which 4% versus 4% were clinically relevant (P = 0.87). After a distal pancreatectomy, 42% of patients treated with sealants versus 52% of patients without sealants developed a POPF (P = 0.03). Of these, 9% versus 12% were clinically relevant (P = 0.19). CONCLUSIONS: The present data do not support the routine use of matrix-bound sealants after a pancreatic resection, as there was no effect on clinically relevant POPF. Larger, well-designed studies are needed to determine the efficacy of sealants in preventing POPF after a pancreatoduodenectomy.

Outcomes of Minimally Invasive Thyroid Surgery - A Systematic Review and Meta-Analysis.

Purpose: Conventional thyroidectomy has been standard of care for surgical thyroid nodules. For cosmetic purposes different minimally invasive and remote-access surgical approaches have been developed. At present, the most used robotic and endoscopic thyroidectomy approaches are minimally invasive video assisted thyroidectomy (MIVAT), bilateral axillo-breast approach endoscopic thyroidectomy (BABA-ET), bilateral axillo-breast approach robotic thyroidectomy (BABA-RT), transoral endoscopic thyroidectomy via vestibular approach (TOETVA), retro-auricular endoscopic thyroidectomy (RA-ET), retro-auricular robotic thyroidectomy (RA-RT), gasless transaxillary endoscopic thyroidectomy (GTET) and robot assisted transaxillary surgery (RATS). The purpose of this systematic review was to evaluate whether minimally invasive techniques are not inferior to conventional thyroidectomy. Methods: A systematic search was conducted in Medline, Embase and Web of Science to identify original articles investigating operating time, length of hospital stay and complication rates regarding recurrent laryngeal nerve injury and hypocalcemia, of the different minimally invasive techniques. Results: Out of 569 identified manuscripts, 98 studies met the inclusion criteria. Most studies were retrospective in nature. The results of the systematic review varied. Thirty-one articles were included in the meta-analysis. Compared to the standard of care, the meta-analysis showed no significant difference in length of hospital stay, except a longer stay after BABA-ET. No significant difference in incidence of recurrent laryngeal nerve injury and hypocalcemia was seen. As expected, operating time was significantly longer for most minimally invasive techniques. Conclusions: This is the first comprehensive systematic review and meta-analysis comparing the eight most commonly used minimally invasive thyroid surgeries individually with standard of care. It can be concluded that minimally invasive techniques do not lead to more complications or longer hospital stay and are, therefore, not inferior to conventional thyroidectomy.

Care after pancreatic resection according to an algorithm for early detection and minimally invasive management of pancreatic fistula versus current practice (PORSCH-trial): design and rationale of a nationwide stepped-wedge cluster-randomized trial.

BACKGROUND: Pancreatic resection is a major abdominal operation with 50% risk of postoperative complications. A common complication is pancreatic fistula, which may have severe clinical consequences such as postoperative bleeding, organ failure and death. The objective of this study is to investigate whether implementation of an algorithm for early detection and minimally invasive management of pancreatic fistula may improve outcomes after pancreatic resection. METHODS: This is a nationwide stepped-wedge, cluster-randomized, superiority trial, designed in adherence to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. During a period of 22 months, all Dutch centers performing pancreatic surgery will cross over in a randomized order from current practice to best practice according to the algorithm. This evidence-based and consensus-based algorithm will provide daily multilevel advice on the management of patients after pancreatic resection (i.e. indication for abdominal imaging, antibiotic treatment, percutaneous drainage and removal of abdominal drains). The algorithm is designed to aid early detection and minimally invasive step-up management of postoperative pancreatic fistula. Outcomes of current practice will be compared with outcomes after implementation of the algorithm. The primary outcome is a composite of major complications (i.e. post-pancreatectomy bleeding, new-onset organ failure and death) and will be measured in a sample size of at least 1600 patients undergoing pancreatic resection. Secondary endpoints include the individual components of the primary endpoint and other clinical outcomes, healthcare resource utilization and costs analysis. Follow up will be up to 90 days after pancreatic resection. DISCUSSION: It is hypothesized that a structured nationwide implementation of a dedicated algorithm for early detection and minimally invasive step-up management of postoperative pancreatic fistula will reduce the risk of major complications and death after pancreatic resection, as compared to current practice. TRIAL REGISTRATION: Netherlands Trial Register: NL 6671. Registered on 16 December 2017.

[TOETVA: thyroid surgery without permanent scar]. / TOETVA: schildklierchirurgie zonder blijvend litteken.

Transoral endoscopic thyroidectomy using a vestibular approach (TOETVA) is the first thyroid surgery that leaves no permanent visible external scar. 3 scopes are placed via the mouth, passing the front of the teeth. The thyroid is then reached and removed by passing over the chin. Only patients with a thyroid nodule of up to 3 cm in diameter are eligible for TOETVA. The most important advantage of this new technique, in comparison with conventional thyroid surgery, is the prevention of a potentially disfiguring scar in the neck. A proctoring programme will be put in place to make it possible to implement this new technique all over the country.

Safety of radiofrequency ablation in patients with locally advanced, unresectable pancreatic cancer: A phase II study.

INTRODUCTION: Radiofrequency ablation (RFA) has been proposed as a new treatment option for locally advanced, unresectable pancreatic cancer (LAPC). In preparation of a randomized controlled trial (RCT), the aim of this phase II study was to assess the safety of RFA for patients with LAPC. MATERIALS AND METHODS: Patients diagnosed with LAPC confirmed during surgical exploration between November 2012 and April 2014 were eligible for inclusion. RFA probes were placed under ultrasound guidance with a safety margin of at least 10 mm from the duodenum and 15 mm from the portomesenteric vessels. During RFA, the duodenum was continuously perfused with cold saline to reduce risk for thermal damage. Primary outcome was defined as the amount of major complications (Clavien-Dindo grade ≥III). RFA-related complications were predefined as: pancreatic fistula, pancreatitis, thermal damage to the portomesenteric vessels and duodenal perforation. RESULTS: In total, 17 patients underwent RFA. Delayed gastric emptying (DGE) requiring endoscopic feeding tube placement occurred in 4 patients (24%) as only major complication. Five patients (29%) had a major complication other than DGE. One (6%) RFA-related major complications occurred. One patient (6%) died due to complications from a biliary leak following hepaticojejunostomy. After evaluation of the first 5 patients, gastrojejunostomy was no longer performed routinely. Since then severe DGE seemed to occur less (3/5 vs. 3/12 grade C DGE). CONCLUSION: RFA is a major, but safe procedure for patients with LAPC if performed with strict predefined safety criteria. A RCT is currently investigating the true effectiveness of RFA in patients with LAPC.