Postoperative outcomes and costs of laparoscopic versus robotic distal pancreatectomy: a propensity-matched analysis.

BACKGROUND: Minimally invasive distal pancreatectomy (MIDP) has established advantages over the open approach. The costs associated with robotic DP (RDP) versus laparoscopic DP (LDP) make the robotic approach controversial. We sought to compare outcomes and cost of LDP and RDP using propensity matching analysis at our institution. METHODS: Patients undergoing LDP or RDP between 2000 and 2021 were retrospectively identified. Patients were optimally matched using age, gender, American Society of Anesthesiologists status, body mass index, and tumor size. Between-group differences were analyzed using the Wilcoxon signed-rank test for continuous data, and the McNemar's test for categorical data. Outcomes included operative duration, conversion to open surgery, postoperative length of stay, pancreatic fistula rate, pseudocyst requiring intervention, and costs. RESULTS: 298 patients underwent MIDP, 180 (60%) were laparoscopic and 118 (40%) were robotic. All RDPs were matched 1:1 to a laparoscopic case with absolute standardized mean differences for all matching covariates below 0.10, except for tumor type (0.16). RDP had longer operative times (268 vs 178 min, p < 0.01), shorter length of stay (2 vs 4 days, p < 0.01), fewer biochemical pancreatic leaks (11.9% vs 34.7%, p < 0.01), and fewer interventional radiological drainage (0% vs 5.9%, p = 0.01). The number of pancreatic fistulas (11.9% vs 5.1%, p = 0.12), collections requiring antibiotics or intervention (11.9% vs 5.1%, p = 0.12), and conversion rates (3.4% vs 5.1%, p = 0.72) were comparable between the two groups. The total direct index admission costs for RDP were 1.01 times higher than for LDP for FY16-19 (p = 0.372), and 1.33 times higher for FY20-22 (p = 0.031). CONCLUSIONS: Although RDP required longer operative times than LDP, postoperative stays were shorter. The procedure cost of RDP was modestly more expensive than LDP, though this was partially offset by reduced hospital stay and reintervention rate.

Radiomics for the prediction of a postoperative pancreatic fistula following a pancreatoduodenectomy: A systematic review and radiomic score quality assessment.

BACKGROUND: Postoperative pancreatic fistula (POPF) is a severe complication following a pancreatoduodenectomy. An accurate prediction of POPF could assist the surgeon in offering tailor-made treatment decisions. The use of radiomic features has been introduced to predict POPF. A systematic review was conducted to evaluate the performance of models predicting POPF using radiomic features and to systematically evaluate the methodological quality. METHODS: Studies with patients undergoing a pancreatoduodenectomy and radiomics analysis on computed tomography or magnetic resonance imaging were included. Methodological quality was assessed using the Radiomics Quality Score (RQS) and Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis (TRIPOD) statement. RESULTS: Seven studies were included in this systematic review, comprising 1300 patients, of whom 364 patients (28 %) developed POPF. The area under the curve (AUC) of the included studies ranged from 0.76 to 0.95. Only one study externally validated the model, showing an AUC of 0.89 on this dataset. Overall adherence to the RQS (31 %) and TRIPOD guidelines (54 %) was poor. CONCLUSION: This systematic review showed that high predictive power was reported of studies using radiomic features to predict POPF. However, the quality of most studies was poor. Future studies need to standardize the methodology. REGISTRATION: not registered.

Case Series of MRI and CT Assessment of Acquired Hepato-Biliary and Pancreatic Transdiaphragmatic Fistulae.

Transdiaphragmatic fistulae are rare conditions characterized by pathological communication between two epithelium-lined surfaces. Hepato-thoracic fistula consists of abnormal communication between the liver and/or the biliary system and the thorax; while the pancreaticopleural fistula consists of abnormal communication between the pancreas and the thorax, the pleuro-biliary fistula represents the more common type. Clinical symptoms and laboratory findings are generally non-specific (e.g., thoracic and abdominal pain, dyspnea, cough, neutrophilia, elevated CPR, and bilirubin values) and initially, first-level investigations, such as chest RX and abdominal ultrasound, are generally inconclusive for the diagnosis. Contrast-enhanced CT represents the first two-level radiological imaging technique, usually performed to identify and evaluate the underlying pathology sustained by transdiaphragmatic fistulae, their complications, and the evaluation of the fistulous tract. When the CT remains inconclusive, other techniques such as MRI and MRCP can be performed. A prompt and accurate diagnosis is crucial because the recognition of fistulae and the precise definition of the fistulous tract have a major impact on the management acquisition process.

Costs of complications following distal pancreatectomy: a systematic review.

BACKGROUND: Postoperative complications following distal pancreatectomy (DP) are common, especially postoperative pancreatic fistula (POPF). In order to design adequate prophylactic strategies, it is of relevance to determine the costs of these complications. An overview of the literature on the costs of complications following DP is lacking. METHODS: A systematic literature search was performed in PubMed, Embase, and Cochrane Library (inception until 1 August 2022). The primary outcome was the costs (i.e. cost differential) of major morbidity, individual complications and prolonged hospital stay. Quality of non-RCTs were assessed using the Newcastle-Ottawa scale. Costs were compared with the use of Purchasing Power parity. This systematic review was registered with PROSPERO (CRD42021223019). RESULTS: Overall, seven studies were included with 854 patients after DP. The rate POPF grade B/C varied between 13% and 27% (based on five studies) with a corresponding cost differential of EUR 18,389 (based on two studies). The rate of severe morbidity varied between 13% and 38% (based on five studies) with a corresponding cost differential of EUR 19,281 (based on five studies). CONCLUSION: This systematic review reported considerable costs for POPF grade B/C and severe morbidity after DP. Prospective databases and studies should report on all complications in a uniform matter to better display the economic burden of complications of DP.

Surgical skills assessment of pancreaticojejunostomy using a simulator may predict patient outcomes: A multicenter prospective observational study.

BACKGROUND: Pancreatoduodenectomy, an advanced surgical procedure with a high complication rate, requires surgical skill in performing pancreaticojejunostomy, which correlates with operative outcomes. We aimed to analyze the correlation between pancreaticojejunostomy assessment conducted in a simulator environment and the operating room and patient clinical outcomes. METHODS: We recruited 30 surgeons (with different experience levels in pancreatoduodenectomy) from 11 institutes. Three trained blinded raters assessed the videos of the pancreaticojejunostomy procedure performed in the operating room using a simulator according to an objective structured assessment of technical skill and a newly developed pancreaticojejunostomy assessment scale. The correlations between the assessment score of the pancreaticojejunostomy performed in the operating room and using the simulator and between each assessment score and patient outcomes were calculated. The participants were also surveyed regarding various aspects of the simulator as a training tool. RESULTS: There was no correlation between the average score of the pancreaticojejunostomy performed in the operating room and that in the simulator environment (r = 0.047). Pancreaticojejunostomy scores using the simulator were significantly lower in patients with postoperative pancreatic fistula than in those without postoperative pancreatic fistula (P = .05). Multivariate analysis showed that pancreaticojejunostomy assessment scores were independent factors in postoperative pancreatic fistula (P = .09). The participants highly rated the simulator and considered that it had the potential to be used for training. CONCLUSION: There was no correlation between pancreaticojejunostomy surgical performance in the operating room and the simulation environment. Surgical skills evaluated in the simulation setting could predict patient surgical outcomes.

Postoperative Pancreatic Fistula Following Traumatic Splenectomy: A Morbid and Costly Complication.

INTRODUCTION: Development of clinically relevant postoperative pancreatic fistula (CR-POPF) in adult splenectomies following trauma occur in 1%-3% of cases. We hypothesized that the use of sutures in splenic hilum ligation compared to staples was associated with a reduced rate of CR-POPF incidence. METHODS: Adult trauma patients (age ≥17 y) that underwent nonelective splenectomy from 2010 to 2020 were retrospectively evaluated from the trauma registries of all three adult level 1 trauma centers in Indiana. Patients were excluded if they were pregnant, currently incarcerated, expired within 72 h of admission, or had a pancreatic injury diagnosed preoperatively or intraoperatively. A Firth logistic regression using a penalized-maximum likelihood estimate for rare events was used for univariate predictive modeling (SPSS 28.0) of surgical technique on CR-POPF development. RESULTS: Four hundred nineteen adult splenectomies following trauma were conducted; 278 were included. CR-POPF developed in 14 cases (5.0%). Sutures alone were used in 200 cases: seven developed CR-POPF (3.5%). Staples alone or in combination with sutures were used in 74 cases: seven developed CR-POPF (9.5%). There was no statistically significant difference between the use of sutures alone compared to the use of staples alone (P = 0.123) or in combination (P = 0.100) in CR-POPF incidence. CONCLUSIONS: Our 10-y retrospective review of CR-POPF finds the complication to be rare but morbid. This study was underpowered to show any difference in surgical technique. However, we do propose a new institutional norm that CR-POPF develop in 5% of splenectomies after trauma and conclude that further study of optimal technique for emergent splenectomy is warranted.

Estimating Fatty Pancreas-A Preoperative Bedside Assessment by Bioelectric Impedance Analysis: Implications for Pancreatic Surgery.

OBJECTIVE: The aim of the study was to evaluate whether fatty pancreas could be estimated by fat mass measurement by preoperative bioelectric impedance analysis. Preoperative computed tomography scan and pathologic evaluation were used as validation methods. Moreover, the 3 methodologies were tested for their ability in predicting postoperative pancreatic fistula. METHODS: Seventy-five patients who underwent pancreatic resection were analyzed. Preoperative computed tomography attenuation in Hounsfield unit (CT-HU) was used to assess fatty pancreas. Bioelectric impedance analysis was performed the day before surgery and fat mass index (FMI) was calculated. Pancreatic steatosis was assessed by pathologists at the line of surgical transection. The ability of the methods in predicting postoperative pancreatic fistula was evaluated by the area under the receiver operating characteristics curves. RESULTS: There was a strong correlation between CT-HU values and grade of pancreatic steatosis evaluated at histology ( r = -0.852, P < 0.001) and a moderate correlation between FMI and histologic pancreatic steatosis ( r = 0.612, P < 0.001) and between CT-HU value and FMI ( r = -0.659, P < 0.001) values. The area under the curve (95% confidence interval) was 0.942 (0.879-1) for histology, 0.924 (0.844-1) for CT-HU, and 0.884 (0.778-0.990) for FMI. CONCLUSIONS: Bioelectric impedance analysis represents a valid alternative to assess pancreatic steatosis.

Organ preserving pancreatic resections offer better long-term conservation of pancreatic function at the expense of high perioperative major morbidity: a fair trade-off for benign or low malignant potential pancreatic neoplasms-a single-center experience.

BACKGROUND: Standard pancreatic resections (SPRs) might have long-term deleterious effects on pancreatic function, without added oncological advantage in low malignant potential (LMP) or benign neoplasms. This study aimed to evaluate outcomes following organ-preserving pancreatic resections (OPPARs) and SPRs. METHOD: Post hoc analysis of patients undergoing OPPAR or SPR for benign or LMP pancreatic tumors from January 2011 to January 2020 at Tata Memorial Hospital, Mumbai. RESULTS: Thirty-six and 114 patients were identified in OPPAR and SPR groups respectively. The overall morbidity (58.3% vs 43.9%, p-0.129) was comparable. Major morbidity (41.7% vs 21.9%, p-0.020), post-operative pancreatic fistula (POPF) (63.9% vs 35.1%, p-0.002), and clinically relevant POPF (41.7% vs 20.2%, p-0.010) were significantly higher with OPPAR. Post-operative endocrine insufficiency (14.9% vs 11.1%, p-0.567), exocrine insufficiency (19.3% vs 0%, p-0.004), and requirement of long-term pancreatic enzyme replacement (17.5% vs 0%, p-0.007) were higher in SPRs. Comparing left-sided and right-sided resections in the entire cohort, incidence of endocrine insufficiency was 17.1% vs 11.2% (p-0.299) and that of exocrine insufficiency was 8.6% vs 20% (p-0.048) respectively. CONCLUSION: OPPAR is associated with high post-operative major morbidity and pancreatic fistula rate but offers long-term benefit due to better preservation of pancreatic function than SPR. The incidence of exocrine insufficiency is higher in right sided as compared to left-sided pancreatic resections.

Counting the cost: financial implications of complications following pancreaticoduodenectomy.

BACKGROUND: Morbidity after pancreaticoduodenectomy (PD) has been reported to be about 30-53%. These complications can double hospital costs. We sought to explore the financial implications of complications after PD in a large institutional database. METHODS: A retrospective analysis of patients undergoing PD from 2010-2017 was performed. Costs for index hospitalization were divided into categories: operating room, postoperative ward, radiology and interventional radiology. Complications were categorized according to the Clavien-Dindo classification. Univariable and mutivariable analysis were performed. RESULTS: Median cost of index admission for 997 patients who underwent PD was $23,704 (range $10,988-$528,531). Patients with major complications incurred significantly greater median costs compared to those without ($40,005 vs $21,306, p < 0.001). Patients with postoperative pancreatic fistula (POPF) grade A, B and C had progressively increasing costs ($32,164, $50,264 and $102,013, p < 0.001). On multivariable analysis ileus/delayed gastric emptying, respiratory failure, clinically significant POPF, thromboembolic complications, reoperation, duration of surgery >240 minutes and male sex were associated with significantly increased costs. CONCLUSION: Complications after PD significantly increase hospital costs. This study identifies the major contributors towards increased cost post-PD. Initiatives that focus on prevention of complications could reduce associated costs and ease financial burden on patients and healthcare organizations.

Clinical and economic validation of grade B postoperative pancreatic fistula subclassification.

BACKGROUND: Grade B postoperative pancreatic fistula represents the largest fraction of postoperative pancreatic fistula. A subclassification of grade B postoperative pancreatic fistula has been recently proposed and seems to better stratify postoperative pancreatic fistula clinical and economic burden. Aim of this study was to validate, from a clinical and economic standpoint, grade B postoperative pancreatic fistula subclassification in patients submitted to pancreaticoduodenectomy. METHODS: All consecutive patients who underwent pancreaticoduodenectomy and developed biochemical leak or postoperative pancreatic fistula were included. Grade B postoperative pancreatic fistula was subclassified into 3 categories (B1: persistent drainage >21 days, B2: pharmacological treatments; B3: interventional procedures). Postoperative pancreatic fistula clinical and economic burden was assessed by evaluating postoperative complications, length of hospital stay, and overall hospital costs. RESULTS: Overall, 289 patients developed biochemical leak or postoperative pancreatic fistula. Of these, 34 had biochemical leak (12%), 25 had grade B1 postoperative pancreatic fistula (9%), 91 had grade B2 postoperative pancreatic fistula (31%), 94 had grade B3 postoperative pancreatic fistula (32%), and 45 experienced grade C postoperative pancreatic fistula (16%). The severity of postoperative complications significantly increased across biochemical leak and postoperative pancreatic fistula categories (P < .001), but it was comparable between biochemical leak and grade B1 postoperative pancreatic fistula. There was no significant difference in terms of length of hospital stay between patients with biochemical leak and those with grade B1 postoperative pancreatic fistula (P = 1.000). Overall hospital costs were similar for patients with biochemical leak and those with grade B1 postoperative pancreatic fistula (P = 1.000), whereas they significantly increased across all the other postoperative pancreatic fistula subgroups. CONCLUSION: A subclassification of grade B postoperative pancreatic fistula can better stratify the increasing clinical burden and economic impact of postoperative pancreatic fistula after pancreaticoduodenectomy. Grade B1 postoperative pancreatic fistula has minimal clinical and economic consequences and can be considered closer to a biochemical leak than to a grade B2 postoperative pancreatic fistula.

Protective peritoneal patch for arteries during pancreatoduodenectomy: good value for money.

PURPOSE: This study proposes and details a simple and inexpensive protective technique of wrapping the hepatic and gastroduodenal artery stumps with a peritoneal patch during pancreatoduodenectomy (PD) in order to decrease post-pancreatectomy hemorrhage (PPH). METHODS: Among the 85 patients who underwent PD between July 2020 and March 2021, 16 patients with high-risk pancreatic anastomosis received a peritoneal patch. The Updated Alternative Fistula Risk Score (ua-FRS) was calculated. Post-operative pancreatic fistula (POPF) and PPH were diagnosed and graded according to the International Study Group of Pancreatic Surgery. The mortality rate was calculated up to 90 days after PD. RESULTS: The mean ua-FRS of the 16 patients was 43% (range: 21-63%). Among them, 6 (38%) experienced clinically relevant-POPF, and a PPH was observed in two patients (13%). In these two patients who required re-intervention, the peritoneal patch was remarkably intact, and neither the gastroduodenal stump nor hepatic artery was involved. None of the patients experienced 90-day mortality. CONCLUSION: Although the outcomes are encouraging, the evaluation of a larger series to assess the effectiveness of the peritoneal protective patch for arteries in a high-risk pancreatic anastomosis is ongoing.

Reducing the risk of postoperative pancreatic fistula in radical gastrectomy: pre-assessment with computed tomography for the diagnosis of pancreatic steatosis.

PURPOSE: To determine whether pancreatic steatosis (PS) is associated with the risk of postoperative pancreatic fistula (POPF) after radical gastrectomy, and if so, to investigate whether pre-assessment by diagnostic imaging can mitigate the risk. METHODS: The clinical records of 276 patients with cStage I gastric cancer who underwent laparoscopic gastrectomy with D1 + lymphadenectomy between 2012 and 2015 were reviewed. In the first phase up to July 2013 (n = 138), PS was classified from computed tomography (CT) findings into type S (superficial fat deposition) or type D (diffuse fatty replacement) and examined for association with POPF. In the second phase (n = 138), the preoperative CT assessment of PS was routinized. Separate samples from pancreatoduodenectomy consistent with each type were histologically examined. RESULTS: In the first phase, the incidence of POPF was significantly higher in group S, but not in group D, compared with normal pancreas (16.3% and 9.1% vs. 3.6%, respectively; P = 0.03). The drain amylase level was lowest in group D, reflecting exocrine insufficiency. Histologically, the loose connective-tissue space between the fat infiltrating the pancreas and the peripancreatic fat containing the lymph nodes was unclear in type D but conserved in type S. In the second phase, surgery was performed with more intention on accurately tracing the dissection plane and significantly lowered incidence of POPF in Group S (16.3% to 2.1%; P = 0.047). CONCLUSION: Peripancreatic lymphadenectomy is more challenging and likely to cause POPF in patients with PS. However, the risk may be reduced using appropriate dissection techniques based on the CT pre-assessment findings.

Clinical and Cost Profile of Controlled Grade B Postoperative Pancreatic Fistula: Rationale for Their Consideration as Low Risk.

BACKGROUND: Despite standardization, the 2016 ISGPF criteria are limited by their wider applicability and oversimplification of grade B POPF. This work applied the 2016 ISGPF grading criteria within a US academic cancer center to verify clinical and fiscal distinctions and sought to improve grading criteria for grade B POPF. METHODS: The 2008-2018 cost and NSQIP data from pancreaticoduodenectomy to postoperative day 90 were merged. All POPFs were coded by 2016 ISGPF criteria. The Clavien-Dindo Classification (CD) defined complication severity. On sub-analyses, grade B POPFs were divided into those with adequate drainage and those requiring additional drainage. Chi-square, ANOVA, and Fisher's least significant difference test were employed. RESULTS: Two hundred thirty-two patients were in the final analyses, 72 (31%) of whom had POPFs: 16 (7%) biochemical leaks, 54 (23%) grade B (28% required additional drainage), and 2 (1%) grade C. There was no significant difference in length of stay, CD, readmission, or cost in patients without a POPF, with biochemical leak or grade B POPF. On sub-analyses, 92% of adequately drained grade B POPFs had CD 1-2 and readmission equivalent to patients without POPF (p > 0.05). One hundred percent of grade B POPF requiring drainage had CD 3-4a, and 67% were readmitted. Cost was significantly increased in grade B POPF requiring additional drainage (p = 0.02) and grade C POPF (p < 0.01). CONCLUSIONS: This analysis did not confirm an incremental increase in morbidity and cost with POPF grade. Sub-analyses enabled accurate clinical and cost distinctions in grade B POPF; adequately drained grade B POPF are low risk and clinically insignificant.

Conservative drain management increases the incidence of grade B postoperative pancreatic fistula without increasing serious complications: Does persistent drainage reflect the quality of pancreatic surgery or institutional policy?

BACKGROUND: Among grade B/C postoperative pancreatic fistula (POPF), the clinical burden of patients treated with persistent drainage alone was reported to be less. As the clinical difference might depend on drain management, we evaluated their clinical burden under conservative drain management. METHODS: We included 292 patients who underwent pancreaticoduodenectomy or distal pancreatectomy between 2013 and 2015. Patients with grade B POPF were categorized into those receiving persistent drainage alone (B-drain) and those receiving other treatments (B-other). The clinical burden of these groups and patients with biochemical leakage (BL) was compared. RESULTS: BL, grade B POPF, and grade C POPF occurred in 42 (14%), 93 (32%), and 4 (1.4%) patients, respectively. The B-drain group comprised 61% of grade B POPF. The overall major morbidity (Clavien-Dindo grade ≥ 3) in the B-drain group was significantly lower than in the B-other group (18% vs 50%, P = .001) but was comparable to that of the BL group (19%, P = .848). The POPF-related major morbidity in the B-drain and B-other group were 0% and 25%, respectively (P < .001). CONCLUSIONS: Under conservative drain management, patients with grade B POPF frequently experienced persistent drainage alone and the clinical burden of B-drain group and BL group was comparable.

Preoperative Nutritional Assessment Using the Controlling Nutritional Status Score to Predict Pancreatic Fistula After Pancreaticoduodenectomy.

Backgound: This study aimed to determine the usefulness of the Controlling Nutritional Status (CONUT) scorescore for predicting postoperative pancreatic fistula (POPF). PATIENTS AND METHODS: Data from 108 consecutive pancreaticoduodenectomy cases performed at the Surgery Department of Iwakuni Clinical Center, from April 2008 to May 2018, were included. Preoperative patient data and postoperative complication data were collected. RESULTS: Of the 108 patients (male=65; female=43; mean age=70 years), 41 (37.9%) had indication for pancreaticoduodenectomy due to pancreatic carcinoma. Grade B or higher POPF was diagnosed in 32 patients (29.6%). In the multivariate analysis, body mass index ≥22 kg/m2 [odds ratio (OR)=5.24; p=0.005], CONUT score ≥4 (OR=3.28; p=0.042), non-pancreatic carcinoma (OR=47.17; p=0.001), and a low computed tomographic contrast attenuation value (late/early ratio) (OR=4.39; p=0.029) were independent risk factors for POPF. CONCLUSION: Patients with high CONUT score are at high risk for POPF. Preoperative nutritional intervention such as immunonutrition might help reduce the POPF risk in these patients.

Decoding Grade B Pancreatic Fistula: A Clinical and Economical Analysis and Subclassification Proposal.

OBJECTIVE: The aim of this study was to describe characteristics and management approaches for grade B pancreatic fistula (B-POPF) and investigate whether it segregates into distinct subclasses. BACKGROUND: The 2016 ISGPS refined definition of B-POPF is predicated on various postoperative management approaches, ranging from prolonged drainage to interventional procedures, but the spectrum of clinical severity within this entity is yet undefined. METHODS: Pancreatectomies performed at 2 institutions from 2007 to 2016 were reviewed to identify B-POPFs and their treatment strategies. Subclassification of B-POPFs into 3 classes was modeled after the Fistula Accordion Severity Grading System (B1: prolonged drainage only; B2: pharmacologic management; B3: interventional procedures). Clinical and economic outcomes, unique from the ISGPS definition qualifiers, were analyzed across subclasses. RESULTS: B-POPF developed in 320 of 1949 patients (16.4%), and commonly required antibiotics (70.3%), prolonged drainage (67.8%), and enteral/parenteral nutrition (54.7%). Percutaneous drainage occurred in 79 patients (24.7%), always in combination with other strategies. Management of B-POPFs was widely heterogeneous with a median of 2 approaches/patient (range 1 to 6) and 38 various strategy combinations used. Subclasses B1-3 comprised 19.1%, 52.2%, and 28.8% of B-POPFs, respectively, and were associated with progressively worse clinical and economic outcomes. These results were confirmed by multivariable analysis adjusted for clinical and operative factors. Notably, distribution of the B-POPF subclasses was influenced by institution and type of resection (P < 0.001), while clinical/demographic predictors proved elusive. CONCLUSION: B-POPF is a heterogeneous entity, where 3 distinct subclasses with increasing clinical and economic burden can be identified. This classification framework has potential implications for accurate reporting, comparative research, and performance evaluation.

Validation of early drain removal after pancreatoduodenectomy based on modified fistula risk score stratification: a population-based assessment.

BACKGROUND: Recent studies on postoperative pancreatic fistula (POPF) prevention following pancreatoduodenectomy (PD) have proposed omission of perioperative drains for negligible/low-risk patients and early drain removal (≤POD3) for intermediate/high-risk patients with POD1 drain amylase levels of ≤5000 U/L, though this has not been validated using a nationwide cohort. METHODS: The ACS-NSQIP targeted pancreatectomy database from 2014 to 2016 was queried to identify patients who underwent PD. Patients with POD1 drain amylase levels of ≤5000 U/L were initially stratified as negligible/low- or intermediate/high-risk based on a previously validated modified fistula risk score (mFRS). Differences in relevant postoperative outcomes were then compared among patients who underwent early (≤POD3) vs. late (≥POD4) drain removal. RESULTS: Among 1825 patients who underwent PD, 1540 (84%) had POD1 drain amylase of ≤5000 U/L: 719 (47%) high-risk and 821 (53%) low-risk. Among high-risk patients, early drain removal (n = 205, 29%) was associated with lower rates of POPF (3% vs. 18%, p < 0.001), clinically relevant (CR)-POPF (2% vs. 15%, p < 0.001), overall morbidity (27% vs. 47%, p < 0.001), serious morbidity (15% vs. 24%, p = 0.007) and hospital length of stay (LOS, 7 vs. 8 days, p < 0.001). Similarly, early drain removal in low-risk patients (n = 273, 33%) was associated with decreased rates of POPF (1% vs. 6%, p = 0.003), CR-POPF (1% vs. 5%, p = 0.014), overall morbidity (28% vs. 41%, p = 0.0003), serious morbidity (8% vs. 14%, p = 0.015) and LOS (6 vs. 8 days, p < 0.001). On multivariate logistic regression analysis, early drain removal remained associated with significantly decreased odds of POPF, CR-POPF, overall and serious morbidity as well as LOS among both high- and low-risk patients (all p < 0.05). CONCLUSIONS: Among patients with POD1 drain amylase ≤5000 U/L following PD, early drain removal (≤POD3) is associated with improved postoperative outcomes among both high- and low-risk patients. Early drain removal based on POD1 drain amylase is indicated regardless of mFRS.