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The aim of this study is to evaluate the effectiveness of TachoSil sponge on distal pancreatectomy remnant stump in reducing the rate and severity of postoperative pancreatic fistula (POPF). All consecutive patients requiring distal pancreatectomy were randomized in 45 centers. The principal end point was onset of “clinically relevant” POPF. Univariate and multivariate analyses were searched for predictive factors. Of the 270 patients randomized (134 with TachoSil; 136 without), 150 (55.6%) patients sustained a POPF [74 clinically relevant and 76 clinically silent (27.4% and 28.1%), respectively]: no statistically significant difference was found between patients sustaining clinically relevant POPF [41 (30.6%) with vs 33 (24.3%) without TachoSil (P = .276)], or overall POPF [73 (54.5%) with vs 77 (56.6%) without TachoSil, (P = .807)], but there were more clinically relevant POPF after hand-sewn (32.3%) versus mechanical closure (19.8%) (P = .025) and, in case of splenic preservation, after splenic vessel ligation (15/32, 46.9%) versus vascular preservation (17/72, 23.6%) (P = .024). Hand-sewn pancreatic remnant closure (P = .023) and splenic vessel ligation in splenic preservation (P = .035) were independent predictive factors for the onset of clinically relevant POPF. TachoSil sponge reinforcement of the proximal remnant after distal pancreatectomy reduced neither the rate nor the severity of POPF. •Several procedures have been proposed to reduce the rate and/or severity of POPF.•This multicenter controlled randomized trial evaluated the usefulness of TachoSil sponge on remnant stump in reducing the rate and severity of POPF.•TachoSil sponge on the proximal remnant after distal pancreatectomy reduced neither the rate nor the severity of POPF.•Hand-sewn pancreatic remnant closure and splenic vessel ligation in splenic preservation were independent predictive factors for the onset of clinically patent POPF.•Negative studies must be published to avoid publication and reporting bias before drawing methodologically sound conclusions as to the usefulness or futility of therapeutic decisions.

Background Although pancreatic duct guidewire placement (P-GW) for achieving selective biliary cannulation is reported to be effective in patients in whom endoscopic retrograde cholangiopancreatography (ERCP) is difficult, this technique entails a possible increased risk of post-ERCP pancreatitis. We conducted a prospective randomized controlled trial to evaluate the prophylactic effect of pancreatic duct stenting on the frequency of post-ERCP pancreatitis in patients who underwent P-GW. Methods Seventy patients who underwent P-GW for achieving selective biliary cannulation were included in this study. Patients were randomly assigned to either the stent group (n = 35) or the no-stent group (n = 35). The pancreatic duct stent used was a 5-Fr, 4-cm-long stent with a single pigtail at the duodenal end (Pit-stent™). The primary endpoint was the frequency of post-ERCP pancreatitis. Results Selective biliary cannulation was achieved in 80% of the stent group and in 94% of the no-stent group (P = 0.15). Post-ERCP pancreatitis occurred in 13% (9 patients; mild). Pancreatic duct stenting was successful in 91% of the stent group. One patient in the stent group developed migration of the stent during the procedure, followed by mild pancreatitis. The frequency of post-ERCP pancreatitis in the stent group was significantly lower than that in the no-stent group (2.9 vs. 23%, relative risk 0.13, confidence interval 0.016, 0.95). Conclusion Pancreatic duct stenting after P-GW for achieving selective biliary cannulation is recommended to reduce the incidence of post-ERCP pancreatitis.

A stent often is placed across the pancreaticojejunostomy. However, there is no report compared between internal drainage and external drainage. We conducted a prospective randomized trial ( NCT00628186 registered at http://ClinicalTrials.gov) with 100 patients who underwent pancreaticoduodenectomy and we compared the effects on postoperative course. The incidence of pancreatic fistula according to the International Study Group on Pancreatic Fistula criteria was not different (external, 20%; vs internal, 26%), and the incidence of the other complications was similar between stent types. The median postoperative hospital stay was 21 days (range, 8–163 d) in the internal drainage group, which was shorter than the median stay of 24 days (range, 21–88 d) in the external drainage group ( P = .016). Both internal drainage and external drainage were safety devices for pancreaticojejunostomy. Internal drainage simplifies postoperative managements and it might shorten postoperative stay for pancreaticoduodenectomy.

Background Data from observational studies suggest that minimally invasive pancreatoduodenectomy (MIPD) is superior to open pancreatoduodenectomy regarding intraoperative blood loss, postoperative morbidity, and length of hospital stay, without increasing total costs. However, several case-matched studies failed to demonstrate superiority of MIPD, and large registry studies from the USA even suggested increased mortality for MIPDs performed in low-volume (<10 MIPDs annually) centers. Randomized controlled multicenter trials are lacking but clearly required. We hypothesize that time to functional recovery is shorter after MIPD compared with open pancreatoduodenectomy, even in an enhanced recovery setting. Methods/design LEOPARD-2 is a randomized controlled, parallel-group, patient-blinded, multicenter, phase 2/3, superiority trial in centers that completed the Dutch Pancreatic Cancer Group LAELAPS-2 training program for laparoscopic pancreatoduodenectomy or LAELAPS-3 training program for robot-assisted pancreatoduodenectomy and have performed ≥ 20 MIPDs. A total of 136 patients with symptomatic benign, premalignant, or malignant disease will be randomly assigned to undergo minimally invasive or open pancreatoduodenectomy in an enhanced recovery setting. After the first 40 patients (phase 2), the data safety monitoring board will assess safety outcomes (not blinded for treatment allocation) and decide on continuation to phase 3. Patients from phase 2 will then be included in phase 3. The primary outcome measure is time (days) to functional recovery. All patients will be blinded for the surgical approach, at least until postoperative day 5, but preferably until functional recovery has been attained. Secondary outcome measures are operative and postoperative outcomes, including clinically relevant complications, mortality, quality of life, and costs. Discussion The LEOPARD-2 trial is designed to assess whether MIPD reduces time to functional recovery, as compared with open pancreatoduodenectomy in an enhanced recovery setting. Trial registration Netherlands Trial Register, NTR5689 . Registered on 2 March 2016.

Background Plastic and covered metal stents need to be removed or exchanged within appropriate time in case of undesirable complications. However, it is not uncommon that patients do not follow the recommendation for further stent management after Endoscopic Retrograde Cholangiopancreatography (ERCP). The effect of short message service (SMS) intervention monthly on the stent removal/exchange adherence in patients after ERCP is unknown at this time. Methods A prospective, randomized controlled study was conducted. After receiving regular instructions, patients were randomly assigned to receive SMS reminding monthly (SMS group) for stent removal/exchange or not (control group). The primary outcome was stent removal/exchange adherence within appropriate time (4 months for plastic stent or 7 months for covered stent). Multivariate analysis was performed to assess factors associated with stent removal/exchange adherence within appropriate time. Intention-to-treat analysis was used. Results A total of 48 patients were randomized, 23 to the SMS group and 25 to the control. Adherence to stent removal/exchange was reported in 78.2 % (18/23) of patients receiving the SMS intervention compared with 40 % (10/25) in the control group (RR 1.98, 95 % CI 1.16–3.31; p  = 0 · 010). Among patients with plastic stent insertion, the median interval time from stent implantation to stent removal/exchange were 90 days in the SMS group and 136 days in the control respectively (HR 0.36, 95 % CI 0.16–0.84, p  = 0.018). No difference was found between the two groups regarding late-stage stent-related complications. The rate of recurrent abdominal pain tended to be lower in SMS group without significant difference (8.7 vs 28 %, p  = 0.144). Multivariate logistic regression analyses revealed that SMS reminding was the only factor associated with adherence of stent removal/exchange (OR 6.73, 95 % CI 1.64–27.54, p  = 0.008). Conclusion This first effectiveness trial demonstrated that SMS reminding monthly could significantly increase the patient adherence to stent removal/exchange after ERCP. Trial registration The study was respectively registered on July 10 in 2016 at ClinicalTrials.gov ( NCT02831127 ).

Endoscopic retrograde cholangiopancreatography (ERCP) is typically performed in prone position. In cases of difficulty in prone position, ERCP can be performed in left lateral position. We aimed to evaluate the efficacy and safety of left lateral position for ERCP compared with those of prone position. Between August 2015 and March 2016, a total of 62 patients with native papilla who underwent ERCP were randomly assigned to undergo the procedure in left lateral position (n = 31) or prone position (n = 31). The outcomes of procedures were compared between the two groups. There were no significant differences between the two groups in terms of the demographic data, indications for ERCP, comorbidities, anticoagulation agents, the types and doses of sedative agents, and procedural durations. The rates of technical success and adverse events were similar (96.8 and 40%, respectively, in left lateral group and 100 and 32.3%, respectively, in prone group). The rates of unintentional pancreatic duct (PD) cannulation and the acquisition of pancreatograms in left lateral group were significantly greater than those in prone group (9/30, 30.0% vs. 3/31, 9.7%, P = 0.046; 7/30, 23.3% vs. 1/31, 3.2%, P = 0.020, respectively). However, there was no significant difference in the rate of post-ERCP pancreatitis (6/30, 20% vs. 5/31, 16.1%, P = 0.694). The left lateral position for ERCP can be as effective and safe as prone position. Due to increased rates of unintended PD cannulation and contrast injection, the initial use of left lateral position may be limited to cases that exhibit difficulty in prone position.

The majority of lethal complications after pancreatic head resection are due to septic complications after leakage from the pancreatojejunostomy. Especially the smooth pancreatic remnant is prone to develop parenchymal leaks from shear forces applied during tying of the sutures. We developed a new mattress technique that avoids such shear forces, and we compared this method to the standard Cattell (duct‐to‐mucosa) technique. A total of 113 patients undergoing standard pancreatic head resection were prospectively randomized to receive either the standard Cattell anastomosis (n = 56) or the new mattress technique (n = 57). All patients were evaluated for surgical and medical complications until discharge. Primary diagnosis and further demographic data compared well between the groups. The time to perform the mattress anastomosis was significantly shorter (15 vs. 22 minutes; p < 0.0001). The incidence of complications at the pancreatojejunostomy, and the length of hospital stay and survival were not significantly different between the two groups; however, a trend toward more reoperations was noted in the Cattell group (10 vs. 5; p < 0.097). The new mattress technique is simple, and our data show that the two techniques yield similar incidences of complications. Therefore the mattress technique for pancreatojejunostomy seems to be safe and is, in our opinion, well suitable for training schedules in pancreatic surgery.

Background Endoscopic retrograde cholangiopancreatography (ERCP) and related procedures can cause abdominal pain and discomfort. Two clinical trials have indicated, using the visual analogue scale (VAS) score, that CO 2 insufflation during ERCP ameliorates the suffering of patients without complications, compared with air insufflation. However, differences in patient suffering between CO 2 and air insufflation after ERCP under deep conscious sedation have not been reported. We focused on the gas volume score (GVS) as an objective indicator of gas volume, and designed a multicenter, prospective, double-blind, randomized, controlled study with CO 2 and air insufflation during ERCP. Methods Between March 2010 and August 2010, 80 patients who required ERCP were enrolled and evenly randomized to receive CO 2 insufflation (CO 2 group) or air insufflation (air group). ERCP and related procedures were performed under deep conscious sedation with fentanyl citrate or pethidine and midazolam or diazepam. The GVS was evaluated as the primary endpoint in addition to the VAS score as the secondary endpoint. Results The GVS after ERCP and related procedures in the CO 2 group was significantly lower than that in the air group (0.14 ± 0.06 vs. 0.31 ± 0.11, P  < 0.01), as well as the rate of increase in GVS ([GVS after − GVS before]/[GVS before ERCP and related procedures] × 100) (3.8 ± 5.9 vs. 21 ± 11.1%, P  < 0.01). VAS scores 3 and 24 h after ERCP and related procedures were comparable between the CO 2 and air groups for abdominal pain, abdominal distension, and nausea. Additionally, VAS scores were not correlated with the GVS. Conclusions CO 2 insufflation during ERCP reduces GVS (bowel gas volume) but not the VAS score of suffering compared with air insufflation. Deep and sufficient sedation during ERCP and related procedures is important for the palliation of patients’ pain and discomfort.

Abstract Pancreatic islet transplantation has become an established approach to β-cell replacement therapy for the treatment of insulin-deficient diabetes. Recent progress in techniques for islet isolation, islet culture, and peritransplant management of the islet transplant recipient has resulted in substantial improvements in metabolic and safety outcomes for patients. For patients requiring total or subtotal pancreatectomy for benign disease of the pancreas, isolation of islets from the diseased pancreas with intrahepatic transplantation of autologous islets can prevent or ameliorate postsurgical diabetes, and for patients previously experiencing painful recurrent acute or chronic pancreatitis, quality of life is substantially improved. For patients with type 1 diabetes or insulin-deficient forms of pancreatogenic (type 3c) diabetes, isolation of islets from a deceased donor pancreas with intrahepatic transplantation of allogeneic islets can ameliorate problematic hypoglycemia, stabilize glycemic lability, and maintain on-target glycemic control, consequently with improved quality of life, and often without the requirement for insulin therapy. Because the metabolic benefits are dependent on the numbers of islets transplanted that survive engraftment, recipients of autoislets are limited to receive the number of islets isolated from their own pancreas, whereas recipients of alloislets may receive islets isolated from more than one donor pancreas. The development of alternative sources of islet cells for transplantation, whether from autologous, allogeneic, or xenogeneic tissues, is an active area of investigation that promises to expand access and indications for islet transplantation in the future treatment of diabetes.

Background Fatty pancreas (FP) was recently recognized as a risk factor for pancreatic ductal adenocarcinoma (PDAC). It is unclear whether computed tomography (CT) can be used to make a FP diagnosis. This study investigated whether CT could provide a predictive value for PDAC by diagnosing FP. Methods The study included 183 consecutive patients who underwent distal pancreatectomy from February 2007 to January 2017, including 75 cases of PDAC and 108 cases of other pancreatic disease. Pancreatic CT density (pancreatic index; PI) at the initial diagnosis was calculated by dividing the CT number in the pancreas by the number in the spleen. To assess whether CT could be used to detect FP, 43 cases were evaluated pathologically for FP. We investigated the correlation between FP and PI, and determined the optimal PI cutoff value for detecting FP using receiver operating characteristics analysis. We then investigated whether the PI value could be used as a predictor for PDAC. Results Fourteen cases (32.6%) were pathologically diagnosed with FP. PI was significantly lower in the FP group versus the non-FP group (0.51 vs. 0.83; p  = 0.0049). ROC analysis indicated that the PI had good diagnostic accuracy for FP diagnosis (cutoff value 0.70; sensitivity 0.79, specificity 0.79). Low PI (≤0.70) was identified in the multivariate analysis as an independent risk factor for PDAC (odds ratio 2.31; p  = 0.023). Conclusions PI was strongly associated with pathological FP, which was independently associated with PDAC. PI shows promise as an imaging predictor for PDAC.