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"Pancreatectomy"
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Robotic-assisted versus laparoscopic left pancreatectomy at a high-volume, minimally invasive center
2019
IntroductionWhile minimally invasive left pancreatectomy has become more widespread and generally accepted over the last decade, opinions on modality of minimally invasive approach (robotic or laparoscopic) remain mixed with few institutions performing a significant portion of both operative approaches simultaneously.Methods247 minimally invasive left pancreatectomies were retrospectively identified in a prospectively maintained institutional REDCap™ database, 135 laparoscopic left pancreatectomy (LLP) and 108 robotic-assisted left pancreatectomy (RLP). Demographics, intraoperative variables, postoperative outcomes, and OR costs were compared between LLP and RLP with an additional subgroup analysis for procedures performed specifically for pancreatic adenocarcinoma (35 LLP and 23 RLP) focusing on pathologic outcomes and 2-year actuarial survival.ResultsThere were no significant differences in preoperative demographics or indications between LLP and RLP with 34% performed for chronic pancreatitis and 23% performed for pancreatic adenocarcinoma. While laparoscopic cases were faster (p < 0.001) robotic cases had a higher rate of splenic preservation (p < 0.001). Median length of stay was 5 days for RLP and LLP, and rate of clinically significant grade B/C pancreatic fistula was approximately 20% for both groups. Conversion rates to laparotomy were 4.3% and 1.8% for LLP and RLP approaches respectively. RLP had a higher rate of readmission (p = 0.035). Pathologic outcomes and 2-year actuarial survival were similar between LLP and RLP. LLP on average saved $206.67 in OR costs over RLP.ConclusionsThis study demonstrates that at a high-volume center with significant minimally invasive experience, both LLP and RLP can be equally effective when used at the discretion of the operating surgeon. We view the laparoscopic and robotic platforms as tools for the modern surgeon, and at our institution, given the technical success of both operative approaches, we will continue to encourage our surgeons to approach a difficult operation with their tool of choice.Graphical abstract
Journal Article
Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial
by
Büchler, Markus W
,
Tomazic, Ales
,
Busch, Olivier RC
in
Aged
,
Biological and medical sciences
,
Clinical trials
2011
The ideal closure technique of the pancreas after distal pancreatectomy is unknown. We postulated that standardised closure with a stapler device would prevent pancreatic fistula more effectively than would a hand-sewn closure of the remnant.
This multicentre, randomised, controlled, parallel group-sequential superiority trial was done in 21 European hospitals. Patients with diseases of the pancreatic body and tail undergoing distal pancreatectomy were eligible and were randomly assigned by central randomisation before operation to either stapler or hand-sewn closure of the pancreatic remnant. Surgical performance was assessed with intraoperative photo documentation. The primary endpoint was the combination of pancreatic fistula and death until postoperative day 7. Patients and outcome assessors were masked to group assignment. Interim and final analysis were by intention to treat in all patients in whom a left resection was done. This trial is registered, ISRCTN18452029.
Between Nov 16, 2006, and July 3, 2009, 450 patients were randomly assigned to treatment groups (221 stapler; 229 hand-sewn closure), of whom 352 patients (177 stapler, 175 hand-sewn closure) were analysed. Pancreatic fistula rate or mortality did not differ between stapler (56 [32%] of 177) and hand-sewn closure (49 [28%] of 175; OR 0·84, 95% CI 0·53–1·33; p=0·56). One patient died within the first 7 days after surgery in the hand-sewn group; no deaths occurred in the stapler group. Serious adverse events did not differ between groups.
Stapler closure did not reduce the rate of pancreatic fistula compared with hand-sewn closure for distal pancreatectomy. New strategies, including innovative surgical techniques, need to be identified to reduce this adverse outcome.
German Federal Ministry of Education and Research.
Journal Article
Nationwide cost-effectiveness and quality of life analysis of minimally invasive distal pancreatectomy
by
Montagnini, Greta
,
Moraldi, Luca
,
Butturini, Giovanni
in
Cost analysis
,
Global health
,
Laparoscopy
2024
BackgroundThis study analyzed the Quality of Life (QoL) and cost-effectiveness of laparoscopic (LDP) versus robotic distal pancreatectomy (RDP).MethodsConsecutive patients submitted to LDP or RDP from 2010 to 2020 in four high-volume Italian centers were included, with a minimum of 12 months of postoperative follow-up were included. QoL was evaluated using the EORTC QLQ-C30 and EQ-5D questionnaires, self-reported by patients. After a propensity score matching, which included BMI, gender, operation time, multiorgan and vascular resections, splenic preservation, and pancreatic stump management, the mean differential cost and Quality-Adjusted Life Years (QALY) were calculated and plotted on a cost-utility plane.ResultsThe study population consisted of 564 patients. Among these, 271 (49%) patients were submitted to LDP, while 293 (51%) patients to RDP. After propensity score matching, the study population was composed of 159 patients in each group, with a median follow-up of 59 months. As regards the QoL analysis, global health and emotional functioning domains showed better results in the RDP group (p = 0.037 and p = 0.026, respectively), whereas the other did not differ. As expected, the median crude costs analysis confirmed that RDP was more expensive than LDP (16,041 Euros vs. 10,335 Euros, p < 0.001). However, the robotic approach had a higher probability of being more cost-effective than the laparoscopic procedure when a willingness to pay more than 5697 Euros/QALY was accepted.ConclusionRDP was associated with better QoL as explored by specific domains. Crude costs were higher for RDP, and the cost-effectiveness threshold was set at 5697 euros/QALY.
Journal Article
Prevalence and Risk Factors for Pancreatic Insufficiency After Partial Pancreatectomy
2022
Background
This study aimed to determine the rate, timing, and predictors of diabetes and exocrine pancreatic insufficiency after pancreatectomy in order to inform preoperative patient counseling and risk management strategies.
Methods
Using prescription claims as a surrogate for disease prevalence, IBM Watson Health MarketScan was queried for claims patterns pre- and post-pancreatectomy. Multivariable models explored associations between clinical characteristics and medication use within 2 years of surgery.
Results
In total, 18.96% of 2,848 pancreaticoduodenectomy (PD) patients and 18.95% of 1,858 distal pancreatectomy (DP) patients had preoperative diabetic medication prescription claims. Fewer (6.6% and 3.88%, respectively) had pancreatic enzyme replacement therapy (PERT) claims. Diabetic medication claims increased to 28.69% after PD and 38.59% after DP [adjusted relative risk (
aRR
) = 1.36 (95% CI 1.27, 1.46)]. Other associated factors included age > 45, medical comorbidity, and obesity. The incidence of new diabetic medication claims among medication naïve patients was 13.78% for PD and 24.7% for DP (
p
< 0.001) with a median 4.7 and 4.9 months post-operatively. The prevalence of PERT claims was 55.97% after PD and 17.06% after DP [
aRR
= 0.32 (0.29, 0.36)]. The incidence of postoperative PERT claims 53.98% (PD) and 14.84% (DP) (
p
< 0.0001). The median time to new PERT claim was 3.0 (PD) and 3.2 (DP) months, respectively. Claims for both diabetic medications and PERT rose sharply after surgery and plateaued within 6 months.
Conclusions
This study defines prevalence, timing, and predictors for post-pancreatectomy insufficiency to inform preoperative counseling, risk modification strategies, and interventions related to quality of life.
Journal Article
Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial
by
van Hilst, Jony
,
van den Boezem, Peter B.
,
Besselink, Marc G.
in
Administration, Oral
,
Analgesics - administration & dosage
,
Biomedicine
2017
Background
Observational cohort studies have suggested that minimally invasive distal pancreatectomy (MIDP) is associated with better short-term outcomes compared with open distal pancreatectomy (ODP), such as less intraoperative blood loss, lower morbidity, shorter length of hospital stay, and reduced total costs. Confounding by indication has probably influenced these findings, given that case-matched studies failed to confirm the superiority of MIDP. This accentuates the need for multicenter randomized controlled trials, which are currently lacking. We hypothesize that time to functional recovery is shorter after MIDP compared with ODP even in an enhanced recovery setting.
Methods
LEOPARD is a randomized controlled, parallel-group, patient-blinded, multicenter, superiority trial in all 17 centers of the Dutch Pancreatic Cancer Group. A total of 102 patients with symptomatic benign, premalignant or malignant disease will be randomly allocated to undergo MIDP or ODP in an enhanced recovery setting. The primary outcome is time (days) to functional recovery, defined as all of the following: independently mobile at the preoperative level, sufficient pain control with oral medication alone, ability to maintain sufficient (i.e. >50%) daily required caloric intake, no intravenous fluid administration and no signs of infection. Secondary outcomes are operative and postoperative outcomes, including clinically relevant complications, mortality, quality of life and costs.
Discussion
The LEOPARD trial is designed to investigate whether MIDP reduces the time to functional recovery compared with ODP in an enhanced recovery setting.
Trial registration
Dutch Trial Register,
NTR5188
. Registered on 9 April 2015
Journal Article
Neoadjuvant chemoradiation therapy with gemcitabine/cisplatin and surgery versus immediate surgery in resectable pancreatic cancer
2015
Background
In nonrandomized trials, neoadjuvant treatment was reported to prolong survival in patients with pancreatic cancer. As neoadjuvant chemoradiation is established for the treatment of rectal cancer we examined the value of neoadjuvant chemoradiotherapy in pancreatic cancer in a randomized phase II trial. Radiological staging defining resectability was basic information prior to randomization in contrast to adjuvant therapy trials resting on pathological staging.
Patients and methods
Patients with resectable adenocarcinoma of the pancreatic head were randomized to primary surgery (Arm A) or neoadjuvant chemoradiotherapy followed by surgery (Arm B), which was followed by adjuvant chemotherapy in both arms. A total of 254 patients were required to detect a 4.33-month improvement in median overall survival (mOS).
Results
The trial was stopped after 73 patients; 66 patients were eligible for analysis. Twenty nine of 33 allocated patients received chemoradiotherapy. Radiotherapy was completed in all patients. Chemotherapy was changed in 3 patients due to toxicity. Tumor resection was performed in 23 vs. 19 patients (A vs. B). The R0 resection rate was 48 % (A) and 52 % (B,
P
= 0.81) and (y)pN0 was 30 % (A) vs. 39 % (B,
P
= 0.44), respectively. Postoperative complications were comparable in both groups. mOS was 14.4 vs. 17.4 months (A vs. B; intention-to-treat analysis;
P
= 0.96). After tumor resection, mOS was 18.9 vs. 25.0 months (A vs. B;
P
= 0.79).
Conclusion
This worldwide first randomized trial for neoadjuvant chemoradiotherapy in pancreatic cancer showed that neoadjuvant chemoradiation is safe with respect to toxicity, perioperative morbidity, and mortality. Nevertheless, the trial was terminated early due to slow recruiting and the results were not significant. ISRCTN78805636; NCT00335543.
Journal Article
Cost-effectiveness of robotic vs laparoscopic distal pancreatectomy. Results from the national prospective trial ROBOCOSTES
2024
IntroductionAlthough several studies report that the robotic approach is more costly than laparoscopy, the cost-effectiveness of robotic distal pancreatectomy (RDP) over laparoscopic distal pancreatectomy (LDP) is still an issue.This study evaluates the cost-effectiveness of the RDP and LDP approaches across several Spanish centres.MethodsThis study is an observational, multicenter, national prospective study (ROBOCOSTES).For one year from 2022, all consecutive patients undergoing minimally invasive distal pancreatectomy were included, and clinical, QALY, and cost data were prospectively collected. The primary aim was to analyze the cost-effectiveness between RDP and LDP.ResultsDuring the study period, 80 procedures from 14 Spanish centres were analyzed.LDP had a shorter operative time than the RDP approach (192.2 min vs 241.3 min, p = 0.004). RDP showed a lower conversion rate (19.5% vs 2.5%, p = 0.006) and a lower splenectomy rate (60% vs 26.5%, p = 0.004).A statistically significant difference was reported for the Comprehensive Complication Index between the two study groups, favouring the robotic approach (12.7 vs 6.1, p = 0.022).RDP was associated with increased operative costs of 1600 euros (p < 0.031), while overall cost expenses resulted in being 1070.92 Euros higher than the LDP but without a statistically significant difference (p = 0.064).The mean QALYs at 90 days after surgery for RDP (0.9534) were higher than those of LDP (0.8882) (p = 0.030). At a willingness-to-pay threshold of 20,000 and 30,000 euros, there was a 62.64% and 71.30% probability that RDP was more cost-effective than LDP, respectively.ConclusionsThe RDP procedure in the Spanish healthcare system appears more cost-effective than the LDP.
Journal Article
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
2022
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.
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.
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).
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.
The Dutch Cancer Society and UMC Utrecht.
Journal Article
Surgical Outcome After Distal Pancreatectomy With and Without Portomesenteric Venous Resection in Patients with Pancreatic Adenocarcinoma: A Transatlantic Evaluation of Patients in North America, Germany, Sweden, and The Netherlands (GAPASURG)
by
Johansen, Karin
,
Wellner, Ulrich F.
,
Augustinus, Simone
in
Adenocarcinoma
,
Adenocarcinoma - pathology
,
Adenocarcinoma - surgery
2024
Background
Pancreatic adenocarcinoma located in the pancreatic body might require a portomesenteric venous resection (PVR), but data regarding surgical risks after distal pancreatectomy (DP) with PVR are sparse. Insight into additional surgical risks of DP-PVR could support preoperative counseling and intraoperative decision making. This study aimed to provide insight into the surgical outcome of DP-PVR, including its potential risk elevation over standard DP.
Methods
We conducted a retrospective, multicenter study including all patients with pancreatic adenocarcinoma who underwent DP ± PVR (2018–2020), registered in four audits for pancreatic surgery from North America, Germany, Sweden, and The Netherlands. Patients who underwent concomitant arterial and/or multivisceral resection(s) were excluded. Predictors for in-hospital/30-day major morbidity and mortality were investigated by logistic regression, correcting for each audit.
Results
Overall, 2924 patients after DP were included, of whom 241 patients (8.2%) underwent DP-PVR. Rates of major morbidity (24% vs. 18%;
p
= 0.024) and post-pancreatectomy hemorrhage grade B/C (10% vs. 3%;
p
= 0.041) were higher after DP-PVR compared with standard DP. Mortality after DP-PVR and standard DP did not differ significantly (2% vs. 1%;
p
= 0.542). Predictors for major morbidity were PVR (odds ratio [OR] 1.500, 95% confidence interval [CI] 1.086–2.071) and conversion from minimally invasive to open surgery (OR 1.420, 95% CI 1.032–1.970). Predictors for mortality were higher age (OR 1.087, 95% CI 1.045–1.132), chronic obstructive pulmonary disease (OR 4.167, 95% CI 1.852–9.374), and conversion from minimally invasive to open surgery (OR 2.919, 95% CI 1.197–7.118), whereas concomitant PVR was not associated with mortality.
Conclusions
PVR during DP for pancreatic adenocarcinoma in the pancreatic body is associated with increased morbidity, but can be performed safely in terms of mortality.
Journal Article