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

Smits, F. Jasmijn; Henry, Anne Claire; Eijck, CH van; Besselink, Marc G.; Or, Busch; Arntz, M; Bollen, T.L.; Delden, OM van; Heuvel, D. Van Den; Leij, Christiaan van der; Lienden, KP van; Moelker, Amber D.; Bonsing, B.; Rinkes, Ihm Borel; Bosscha, K.; Dam, R. Van; Festen, S; Koerkamp, B. Groot; Harst, Erwin van der; Hingh, I. de; Kazemier, Geert; Liem, Mike S L; Kolk, BM van der; Meijer, Vincent E de; Patijn, G.A.; Roos, Daphne; Schreinemakers, JM; Wit, F; Werkhoven, CH van; Molenaar, I. Quintus; Santvoort, H. van

doi:10.21203/rs.2.19292/v2

Cited by 7 publications

(12 citation statements)

References 39 publications

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“…The overall rate of POPF after MIS pancreatoduodenectomy in the current study (41.1%) is higher than previously reported, whereas the mortality rate (3.1%) is comparable to other retrospective studies describing first experiences with robotic and laparoscopic pancreatoduodenectomy (1.7% vs 1.4% and 4.0%) [ 9 , 42 , 43 ]. The high rate of POPF may be partially explained by the proactive drainage approach as was implemented in the nationwide randomized PORSCH trial which led to a 50% reduction of mortality after pancreatoduodenectomy [ 44 ]. Clearly, also a learning curve effect cannot be excluded.…”

Section: Discussionmentioning

confidence: 99%

Impact of shifting from laparoscopic to robotic surgery during 600 minimally invasive pancreatic and liver resections

et al. 2022

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Background Many centers worldwide are shifting from laparoscopic to robotic minimally invasive hepato-pancreato-biliary resections (MIS-HPB) but large single center series assessing this process are lacking. We hypothesized that the introduction of robot-assisted surgery was safe and feasible in a high-volume center. Methods Single center, post-hoc assessment of prospectively collected data including all consecutive MIS-HPB resections (January 2010–February 2022). As of December 2018, all MIS pancreatoduodenectomy and liver resections were robot-assisted. All surgeons had participated in dedicated training programs for laparoscopic and robotic MIS-HPB. Primary outcomes were in-hospital/30-day mortality and Clavien-Dindo ≥ 3 complications. Results Among 1875 pancreatic and liver resections, 600 (32%) were MIS-HPB resections. The overall rate of conversion was 4.3%, Clavien-Dindo ≥ 3 complications 25.7%, and in-hospital/30-day mortality 1.8% (n = 11). When comparing the period before and after the introduction of robotic MIS-HPB (Dec 2018), the overall use of MIS-HPB increased from 25.3 to 43.8% (P < 0.001) and blood loss decreased from 250 ml [IQR 100–500] to 150 ml [IQR 50–300] (P < 0.001). The 291 MIS pancreatic resections included 163 MIS pancreatoduodenectomies (52 laparoscopic, 111 robotic) with 4.3% conversion rate. The implementation of robotic pancreatoduodenectomy was associated with reduced operation time (450 vs 361 min; P < 0.001), reduced blood loss (350 vs 200 ml; P < 0.001), and a decreased rate of delayed gastric emptying (28.8% vs 9.9%; P = 0.009). The 309 MIS liver resections included 198 laparoscopic and 111 robotic procedures with a 3.6% conversion rate. The implementation of robotic liver resection was associated with less overall complications (24.7% vs 10.8%; P = 0.003) and shorter hospital stay (4 vs 3 days; P < 0.001). Conclusion The introduction of robotic surgery was associated with greater implementation of MIS-HPB in up to nearly half of all pancreatic and liver resections. Although mortality and major morbidity were not affected, robotic surgery was associated with improvements in some selected outcomes. Ultimately, randomized studies and high-quality registries should determine its added value. Graphical Abstract

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Section: Discussionmentioning

confidence: 99%

Impact of shifting from laparoscopic to robotic surgery during 600 minimally invasive pancreatic and liver resections

et al. 2022

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“…Trends in annual rates of all cause in-hospital mortality (A) and failure to rescue (B) among 4227 patients after pancreatoduodenectomy in the Netherlands. *A best practice algorithm for early recognition and management of complications after pancreatic resection (PORSCH trial) was implemented in all 16 Dutch centers performing pancreatic surgery in 2018 to 2019 12 …”

Section: Resultsmentioning

confidence: 99%

“…This may suggest that in the latest period complications were treated more adequately. In 2018 and 2019, the nationwide stepped-wedge cluster-randomized PORSCH trial implemented an algorithm for early recognition and minimally invasive management of complications after pancreatic surgery in all pancreatic centers in the Netherlands 12 . Based on changes in vital signs, white blood cell count, and c-reactive protein, the algorithm dictated low-threshold use of abdominal computed tomography, radiologic catheter drainage, and antibiotic treatment.…”

Section: Discussionmentioning

confidence: 99%

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Outcome of Pancreatic Surgery During the First 6 Years of a Mandatory Audit Within the Dutch Pancreatic Cancer Group

Suurmeijer¹,

Henry²,

Bonsing³

et al. 2022

Annals of Surgery

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Objective: To describe outcome after pancreatic surgery in the first 6 years of a mandatory nationwide audit. Background: Within the Dutch Pancreatic Cancer Group, efforts have been made to improve outcome after pancreatic surgery. These include collaborative projects, clinical auditing, and implementation of an algorithm for early recognition and management of postoperative complications. However, nationwide changes in outcome over time have not yet been described. Methods: This nationwide cohort study included consecutive patients after pancreatoduodenectomy (PD) and distal pancreatectomy from the mandatory Dutch Pancreatic Cancer Audit (January 2014–December 2019). Patient, tumor, and treatment characteristics were compared between 3 time periods (2014–2015, 2016–2017, and 2018–2019). Short-term surgical outcome was investigated using multilevel multivariable logistic regression analyses. Primary endpoints were failure to rescue (FTR) and in-hospital mortality. Results: Overall, 5345 patients were included, of whom 4227 after PD and 1118 after distal pancreatectomy. After PD, FTR improved from 13% to 7.4% [odds ratio (OR) 0.64, 95% confidence interval (CI) 0.50–0.80, P<0.001] and in-hospital mortality decreased from 4.1% to 2.4% (OR 0.68, 95% CI 0.54–0.86, P=0.001), despite operating on more patients with age >75 years (18%–22%, P=0.006), American Society of Anesthesiologists score ≥3 (19%–31%, P<0.001) and Charlson comorbidity score ≥2 (24%–34%, P<0.001). The rates of textbook outcome (57%–55%, P=0.283) and major complications remained stable (31%–33%, P=0.207), whereas complication-related intensive care admission decreased (13%–9%, P=0.002). After distal pancreatectomy, improvements in FTR from 8.8% to 5.9% (OR 0.65, 95% CI 0.30–1.37, P=0.253) and in-hospital mortality from 1.6% to 1.3% (OR 0.88, 95% CI 0.45–1.72, P=0.711) were not statistically significant. Conclusions: During the first 6 years of a nationwide audit, in-hospital mortality and FTR after PD improved despite operating on more high-risk patients. Several collaborative efforts may have contributed to these improvements.

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“…Patients were excluded if they underwent a total or subtotal pancreatectomy without a pancreaticoenteric anastomosis, or if the primary outcome was not registered. Patients were also excluded if they were enrolled in the intervention arm of the PORSCH trial because of the influence on the incidence of grade B/C POPF due to the nature of the study 20 . From February 2018 to December 2019 all Dutch pancreatic cancer centers participated in the nationwide stepped-wedge randomized controlled PORSCH trial.…”

Section: Methodsmentioning

confidence: 99%

Fistula Risk Score for Auditing Pancreatoduodenectomy

et al. 2022

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Objective: To develop a fistula risk score for auditing, to be able to compare postoperative pancreatic fistula (POPF) after pancreatoduodenectomy among hospitals. Background: For proper comparisons of outcomes in surgical audits, case-mix variation should be accounted for. Methods: This study included consecutive patients after pancreatoduodenectomy from the mandatory nationwide Dutch Pancreatic Cancer Audit. Derivation of the score was performed with the data from 2014 to 2018 and validation with 2019 to 2020 data. The primary endpoint of the study was POPF (grade B or C). Multivariable logistic regression analysis was performed for case-mix adjustment of known risk factors. Results: In the derivation cohort, 3271 patients were included, of whom 479 (14.6%) developed POPF. Male sex [odds ratio (OR)=1.34; 95% confidence interval (CI): 1.09–1.66], higher body mass index (OR=1.07; 95% CI: 1.05–1.10), a final diagnosis other than pancreatic ductal adenocarcinoma/pancreatitis (OR=2.41; 95% CI: 1.90–3.06), and a smaller duct diameter (OR=1.43/mm decrease; 95% CI: 1.32–1.55) were independently associated with POPF. Diabetes mellitus (OR=0.73; 95% CI: 0.55–0.98) was independently associated with a decreased risk of POPF. Model discrimination was good with a C-statistic of 0.73 in the derivation cohort and 0.75 in the validation cohort (n=913). Hospitals differed in particular in the proportion of pancreatic ductal adenocarcinoma/pancreatitis patients, ranging from 36.0% to 58.1%. The observed POPF risk per center ranged from 2.9% to 25.4%. The expected POPF rate based on the 5 risk factors ranged from 11.6% to 18.0% among hospitals. Conclusions: The auditing fistula risk score was successful in case-mix adjustment and enables fair comparisons of POPF rates among hospitals.

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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

Cited by 7 publications

References 39 publications

Impact of shifting from laparoscopic to robotic surgery during 600 minimally invasive pancreatic and liver resections

Impact of shifting from laparoscopic to robotic surgery during 600 minimally invasive pancreatic and liver resections

Outcome of Pancreatic Surgery During the First 6 Years of a Mandatory Audit Within the Dutch Pancreatic Cancer Group

Fistula Risk Score for Auditing Pancreatoduodenectomy

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