To drain or not to drain after distal pancreatectomy: reflexions on the PANDORINA trial
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PROVIDER: S-EPMC11336532 | biostudies-literature | 2024 Jul
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Project description:Intraperitoneal prophylactic drain (IPD) use in distal pancreatectomy (DP) is still controversial. A survey was carried out through the Italian community of pancreatic surgeons using institutional emails, Twitter, and Facebook accounts of the Italian Association for the Study of the Pancreas (AISP) and the Italian Association of Hepato-biliary-pancreatic Surgery (AICEP). The survey was structured to learn surgeons' practice in using IPD through questions and one clinical vignette. Respondents were asked to report their regrets for omission and commission regarding the IPD use for the clinical scenario, eliciting a scale between 0 (no regret) and 100 (maximum regret). The threshold model and a multilevel mixed regression were built to identify respondents' attitudes. One hundred six surgeons completed the survey. Sixty-three (59.4%) respondents confirmed using at least 1 drain, while 43 (40.6%) placed 2 IPDs. Only 13 respondents (12.3%) declared a change in IPD strategy in patients at high risk of clinically relevant postoperative pancreatic fistula (CR-POPF), while 9 (9.4%) respondents changed their strategy in low-risk POPF situations. Thirty-five (35.5%) respondents declared they would remove the IPD within the third postoperative day (POD) in the absence of CR-POPF suspicion. The median omission regret, which proved to be the wrong decision, was 80 (50-100, IQR). The median regret due to the commission of IPD, which turned out to be useless, was 2.5 (1-20, IQR). The CR-POPF probability threshold at which drainage omission was the less regrettable choice was 7% (1-35, IQR). The threshold to perceive drain omission as the least regrettable choice was higher in female surgeons (P < 0.001), in surgeons who modulated the strategies based on the risk of CR-POPF, and in high volume centers (p = 0.039). The threshold was lower in surgeons who performed minimally invasive distal pancreatectomy (P < 0.001), adopted a closed system (P < 0.001), placed two IPDs (P < 0.001), or perceived the IPD as important to prevent reintervention (p = 0.047). Drain management after DP remains very heterogeneous among surgeons. The regret model suggested that IPD omission could be performed in low-risk patients (7% of CR-POPF), leading to low regret in the case of the wrong decision, making it an acceptable clinical decision.
| S-EPMC11876192 | biostudies-literature
Project description:AimThe aim of this study was to evaluate the intra-abdominal status related to postoperative pancreatic fistula by combining postoperative fluid collection and drain amylase levels.MethodsWe retrospectively reviewed the data of 203 patients who underwent distal pancreatectomy and classified their postoperative abdominal status into four groups based on postoperative fluid collection size and drain amylase levels. We also evaluated the incidence of clinically relevant postoperative pancreatic fistula in each group according to C-reactive protein values.ResultsThe incidence of clinically relevant postoperative pancreatic fistula in the entire cohort (n = 203) was 28.1%. Multivariate analysis revealed that postoperative fluid collection, drain amylase levels, and C-reactive protein levels are considerable risk factors for clinically relevant postoperative pancreatic fistula. In the subgroup with large postoperative fluid collection and high drain amylase levels, 65.9% of patients developed clinically relevant postoperative pancreatic fistula. However, no significant difference was observed in C-reactive protein levels between patients with clinically relevant postoperative pancreatic fistula and those without it. In contrast, in the subgroup with a large postoperative fluid collection size or a high amylase level alone, a significant difference was observed in C-reactive protein values between the patients with clinically relevant postoperative pancreatic fistula and those without it.ConclusionPostoperative fluid collection status and the C-reactive protein value provide a more precise assessment of intra=abdominal status related to postoperative pancreatic fistula after distal pancreatectomy. This detailed analysis may be a clinically reasonable approach to individual drain management.
| S-EPMC10914692 | biostudies-literature
Project description:BackgroundThe pancreatic transection method during distal pancreatectomy is thought to influence postoperative fistula rates. Yet, the optimal technique for minimizing fistula occurrence is still unclear. The present randomized controlled trial compared stapled versus ultrasonic transection in elective distal pancreatectomy.MethodsPatients undergoing distal pancreatectomy from July 2018 to July 2020 at two high-volume institutions were considered for inclusion. Exclusion criteria were contiguous organ resection and a parenchymal thickness > 17 mm on intraoperative ultrasound. Eligible patients were randomized in a 1:1 ratio to stapled transection (Endo GIA Reinforced Reload with Tri-Staple Technology®) or ultrasonic transection (Harmonic Focus® + or Harmonic Ace® + shears). The primary endpoint was postoperative pancreatic fistula. Secondary endpoints included overall complications, abdominal collections, and length of hospital stay.ResultsOverall, 72 patients were randomized in the stapled transection arm and 73 patients in the ultrasonic transection arm. Postoperative pancreatic fistula occurred in 23 patients (16%), with a comparable incidence between groups (12% in stapled transection versus 19% in ultrasonic dissection arm, p = 0.191). Overall complications did not differ substantially (35% in stapled transection versus 44% in ultrasonic transection arm, p = 0.170). There was an increased incidence of abdominal collections in the ultrasonic dissection group (32% versus 14%, p = 0.009), yet the need for percutaneous drain did not differ between randomization arms (p = 0.169). The median length of stay was 8 days in both groups (p = 0.880). Intraoperative blood transfusion was the only factor independently associated with postoperative pancreatic fistula on logistic regression analysis (OR 4.8, 95% CI 1.2-20.0, p = 0.032).ConclusionThe present randomized controlled trial of stapled versus ultrasonic transection in elective distal pancreatectomy demonstrated no significant difference in postoperative pancreatic fistula rates and no substantial clinical impact on other secondary endpoints.
| S-EPMC9085691 | biostudies-literature
Project description:Distal pancreatectomy with en-bloc splenectomy has been considered the standard technique for management of benign and malignant pancreatic disorders. However, splenic preservation has recently been advocated. The aim of this study was to review the experiences of distal pancreatectomy using the open or the laparoscopic approach and to critically discuss the need to perform splenectomy. Original articles published in the English literature of peer-reviewed medical journals were selected for detailed analysis. In patients with malignant neoplasms in the body-tail of the pancreas, splenectomy has a negative influence on long-term survival after resection. The incidence of diabetes after spleen-preserving distal pancreatectomy for chronic pancreatitis is less than after en-bloc splenectomy. Spleen salvage eliminates the risk of overwhelming infections. Laparoscopic spleen-preserving distal pancreatectomy is feasible and safe. Laparoscopic spleen-preserving distal pancreatectomy may be preferable for the advantages of a minimally invasive approach.
| S-EPMC2023931 | biostudies-other
Project description:BackgroundIschemic gastropathy (IG) is a major complication after distal pancreatectomy with en bloc celiac axis resection (DP-CAR) for locally advanced body/tail pancreatic ductal adenocarcinoma (PDAC), and its incidence is still unknown.MethodsTo evaluate the occurrence of IG, 77 and 18 consecutive patients with body/tail PDAC were analyzed in a retrospective and a prospective study, respectively. We utilized perioperative gastroendoscopy, Gastrointestinal Quality of Life Index (GIQLI) score, and quantitative assessment for gastric arterial blood flow using the HyperEye Medical System (HEMS) with indocyanine green (ICG) fluorescence imaging in the prospective arm.ResultsIn the retrospective arm, no significant difference was noted in the occurrence rate of IG between the DP-CAR (8.7%) and DP groups (5.5%). In the prospective arm, the postoperative endoscopic scores were significantly higher in the DP-CAR group (45%) than in the DP group (11%) (p < .0007) despite no difference in the GIQLI score. The ICG-HEMS imaging system demonstrated more delayed arterial flow velocity in the IG (+) group (p < .028), but showed no significant difference in arterial flow volume compared to the IG (-) group.ConclusionThis is the first demonstration assessing IG incidence after DP-CAR using multiple methods. Despite the high IG rate, gastric arterial flow volume was almost equally maintained in DP-CAR patients with or without IG compared with the DP group. We should note the fact that many of the IG patients do not present with typical symptoms, and proper treatment is required for those "silent" IG patients.
| S-EPMC8083012 | biostudies-literature
Project description: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.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.The LEOPARD trial is designed to investigate whether MIDP reduces the time to functional recovery compared with ODP in an enhanced recovery setting.Dutch Trial Register, NTR5188 . Registered on 9 April 2015.
| S-EPMC5385082 | biostudies-other
Project description:BackgroundFirst postoperative day drain fluid amylase (DFA1) <5000 U/L is commonly used for early drain removal. We manage patients with risk-stratified pancreatectomy care pathways determined preoperatively by risk for postoperative pancreatic fistula. We hypothesized that preoperative risk stratification would yield unique DFA1/DFA3 cutoffs for safe early drain removal.MethodsPatients with DFA1/DFA3 values after pancreaticoduodenectomy or distal pancreatectomy were identified. Patients were risk stratified as "low-risk pancreaticoduodenectomy," "high-risk pancreaticoduodenectomy," or "distal pancreatectomy." Receiver operator characteristic analyses yielded clinically relevant sensitivity thresholds for International Study Group on Pancreatic Surgery grade B/C postoperative pancreatic fistulas.ResultsFrom October 2016 to April 2018, 174 patients were preoperatively stratified as low-risk pancreaticoduodenectomy (n = 78, 45%), high-risk pancreaticoduodenectomy (n = 51, 29%), and distal pancreatectomy (n = 45, 26%). B/C postoperative pancreatic fistulas developed in 3% (n = 2) of low-risk pancreaticoduodenectomies, 37% (n = 19) of high-risk pancreaticoduodenectomies, and 24% (n = 11) of distal pancreatectomies (low- vs high-risk pancreaticoduodenectomy P < .001, low-risk pancreaticoduodenectomy versus distal pancreatectomy P = .004, high-risk pancreaticoduodenectomy versus distal pancreatectomy P = .25). B/C postoperative pancreatic fistulas occurred in 16% (n = 21) pancreaticoduodenectomy patients (high- + low-risk pancreaticoduodenectomy), and B/C postoperative pancreatic fistulas were excluded in pancreaticoduodenectomy with 100% sensitivity if DFA1 ≤ 136 or DFA3 ≤ 93. DFA1 < 5000 excluded B/C postoperative pancreatic fistulas with only 57% sensitivity after pancreaticoduodenectomy. Exclusion of B/C postoperative pancreatic fistulas occurred with 100% sensitivity if DFA1 ≤ 661 or DFA3 ≤ 141 in low-risk pancreaticoduodenectomy patients, DFA1 ≤ 136 or DFA3 ≤ 93 in high-risk pancreaticoduodenectomy patients, and DFA1 < 49 or DFA3 < 26 in distal pancreatectomy patients.ConclusionPreoperative risk stratification results in unique DFA1/DFA3 thresholds to exclude B/C postoperative pancreatic fistulas, thus allowing for safe drain removal and potential for accelerated discharge. Rather than applying generic DFA cutoffs based on national databases, we propose institution-specific DFA1 and DFA3 values tailored to 3 replicable postoperative pancreatic fistula-risk pathways.
| S-EPMC7288221 | biostudies-literature
Project description:BackgroundThe placement of prophylactic intra-abdominal drains has been common practice in abdominal operations including pancreatic surgery. The PANDRA trial showed that the omission of drains following pancreatic head resection was non-inferior to intra-abdominal drainage in terms of postoperative reinterventions and superior in terms of clinically relevant pancreatic fistula rate and fistula-associated complications. The aim of the present PANDRA II trial is to evaluate the clinical outcome with versus without prophylactic drain placement after distal pancreatectomy.MethodsThe PANDRA II trial is a mono-center, randomized controlled, non-inferiority trial with two parallel study groups. In the control group at least one passive intra-abdominal drain is placed at the pancreatic resection margin. In the experimental group no drains are placed. The primary endpoint of this trial will be the Comprehensive Complication Index (CCI) measuring all postoperative complications within 90 days. Secondary endpoints are in-hospital mortality and morbidity, including the rates of postoperative pancreatic fistula, chyle leak, postpancreatectomy hemorrhage, delayed gastric emptying, reinterventions and reoperations, surgical site infection, and abdominal fascia dehiscence. Moreover, length of hospital stay, duration of intensive care unit stay, and the rate of readmission after discharge from hospital (up to day 90 after surgery) are assessed. We will need to analyze 252 patients to test the hypothesis that no drainage is non-inferior to drain placement in terms of the CCI (δ 7.5 points) in a one-sided t test with a one-sided level of significance of 2.5% and a power of 80%.DiscussionThe results of the PANDRA II trial will help to evaluate the effect of an omission of prophylactic intraperitoneal drainage on the rate of complications after open or minimally invasive distal pancreatectomy.Trial registrationGerman Clinical Trials Register (DRKS), DRKS00013763 . Registered on 6 March 2018.
| S-EPMC6555976 | biostudies-literature
Project description: Not available
| S-EPMC10364730 | biostudies-literature
Project description:BackgroundRadical antegrade modular pancreatosplenectomy (RAMPS) is an isolation procedure in pancreatosplenectomy for pancreatic body/tail cancer. Connective tissues around the bifurcation of the celiac axis are dissected, followed by median-to-left retroperitoneal dissection. This procedure has the potential to isolate blood and lymphatic flow to the area of the pancreatic body/tail and the spleen to be excised. This is achieved by division of the inflow artery, transection of the pancreas, and then division of the outflow vein in the early phases of surgery. In cases of pancreatic ductal adenocarcinoma (PDAC), the procedure has been shown to decrease intraoperative blood loss and increase R0 resection rate by complete clearance of the lymph nodes. This trial investigates whether the isolation procedure can prolong the survival of patients with pancreatic ductal adenocarcinoma who undergo distal pancreatosplenectomy (DPS) compared with those that undergo the conventional approach.Methods/designPatients with PDAC scheduled to undergo DPS are randomized before surgery to undergo either a conventional procedure (arm A) or to undergo the isolation procedure (arm B). In arm A, the pancreatic body, tail, and spleen are mobilized, followed by removal of the regional lymph nodes. The splenic vein is transected at the end of the procedure. The timing of division of the splenic artery (SA) is not restricted. In arm B, regional lymph nodes are dissected, then we transect the root of the SA, the pancreas, then the splenic vein. At the end of the procedure, the pancreatic body/tail and spleen are mobilized and removed. In total, 100 patients from multiple Japanese high-volume centers will be randomized. The primary endpoint is 2-year recurrence-free survival by intention-to-treat analysis. Secondary endpoints include intraoperative blood loss, R0 resection rate, and overall survival.DiscussionIf this trial shows that the isolation procedures can improve survival with a similar R0 rate and with a similar number of lymph node dissections to the conventional procedure, the isolation procedure is expected to become a standard procedure during DPS for PDAC. Conversely, if there were no significant differences in endpoints between the groups, it would demonstrate justification of either procedure from surgical and oncological points of view.Trial registrationUMIN Clinical Trials Registry UMIN000041381 . Registered on 10 August 2020. ClinicalTrials.gov NCT04600063 . Registered on 22 October 2020.
| S-EPMC8447574 | biostudies-literature