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Preoperative biliary drainage is often performed in patients with obstructive jaundice caused by cancer of the pancreatic head, but the benefit of the procedure is unclear. This randomized trial compared 4 to 6 weeks of preoperative biliary drainage, followed by surgery, with immediate surgery alone for cancer of the pancreatic head. The drainage procedure increased morbidity and did not decrease the rate of surgical complications. This randomized trial compared 4 to 6 weeks of preoperative biliary drainage, followed by surgery, with immediate surgery alone for cancer of the pancreatic head. The drainage procedure increased morbidity and did not decrease the rate of surgical complications. Obstructive jaundice is the most common symptom in patients with periampullary cancer (located near the ampulla of Vater) or cancer of the pancreatic head. For patients with a resectable tumor who have no radiologic evidence of metastasis, surgical resection is the only option for cure. 1 – 3 Since surgery in patients with jaundice is thought to increase the risk of postoperative complications, preoperative biliary drainage was introduced to improve the postoperative outcome. 4 In several experimental studies and retrospective case series, preoperative biliary drainage reduced morbidity and mortality after surgery. 4 – 7 However, two meta-analyses of randomized trials and a systematic review of . . .

Pancreatic surgery remains associated with significant morbidity. Pancreatoduodenectomy (PD) with high-risk stigmata for postoperative pancreatic fistula (POPF) may delay or hinder administration of adjuvant therapy. Total pancreatectomy (TP) prevents POPF-associated complications but implies permanent exocrine and endocrine insufficiency. Islet autotransplantation (IAT) has the potential to compensate endocrine function. XANDTX is a single-centre randomized controlled pilot trial comparing high-risk PD with TP and simultaneous IAT in patients with periampullary cancer. After screening for eligibility and obtaining informed consent, a total of 32 adult patients will be intraoperatively randomized in a 1:1 ratio. The primary hypothesis is that TP with IAT prevents POPF-associated complications and leads to a shorter period to initiation of adjuvant therapy and a higher overall rate of adjuvant therapy administration. Secondary endpoints include perioperative morbidity and mortality, metabolic outcome, quality of life (QoL) and oncological long-term outcome. Each patient will be followed up for 5 years. The XANDTX pilot trial will aim to provide surgical and oncological feasibility and safety data of total pancreatectomy with simultaneous islet autotransplantation in management of resectable periampullary cancer. The results will form the basis for a further confirmatory controlled study. This study was registered on ClinicalTrials.gov (NCT05843877) on February 27, 2023 and EudraCT (2023-507773-17-00) on April 18, 2024.

Postoperative pancreatic fistula is the leading cause of death and morbidity after pancreaticoduodenectomy. However, the best reconstruction method to reduce occurrence of fistula is debated. We did a multicentre, randomised superiority trial to compare the outcomes of different reconstructive techniques in patients undergoing pancreaticoduodenectomy for pancreatic or periampullary tumours. Patients aged 18–85 years with confirmed or suspected neoplasms of the pancreas, distal bile duct, ampulla vateri, duodenum, or periampullary tumours were eligible for inclusion. An internet-based platform was used to randomly assign patients to either pancreaticojejunostomy or pancreaticogastrostomy as reconstruction after pancreaticoduodenectomy, using permuted blocks with six patients per block. Within each centre the randomisation was stratified on the pancreatic duct diameter (≤3 mm vs >3 mm) measured at the time of surgery. The primary endpoint was the occurrence of clinical postoperative pancreatic fistula (grade B or C) as defined by the International Study Group on Pancreatic Fistula. The study was not masked and analyses were done by intention to treat. Patient follow-up was closed 2 months after discharge from the hospital. This study is registered with ClinicalTrials.gov, number NCT00830778. Between June, 2009, and August, 2012, we randomly allocated 167 patients to receive pancreaticojejunostomy and 162 to receive pancreaticogastrostomy. 33 (19·8%) patients in the pancreaticojejunostomy group and 13 (8·0%) in the pancreaticogastrostomy group had clinical postoperative pancreatic fistula (OR 2·86, 95% CI 1·38–6·17; p=0·002). The overall incidence of postoperative complications did not differ significantly between the groups (99 in the pancreaticojejunostomy group vs 100 in the pancreaticogastrostomy group), although more events in the pancreaticojejunostomy group were of grade ≥3a than in the pancreaticogastrostomy group (39 vs 35). In patients undergoing pancreaticoduodenectomy for pancreatic head or periampullary tumours, pancreaticogastrostomy is more efficient than pancreaticojejunostomy in reducing the incidence of postoperative pancreatic fistula. Funding Johnson & Johnson Medical Devices, Belgium.

Background Minimally invasive pancreatoduodenectomy (MIPD) aims to reduce the negative impact of surgery as compared to open pancreatoduodenectomy (OPD) and is increasingly becoming part of clinical practice for selected patients worldwide. However, the safety of MIPD remains a topic of debate and the potential shorter time to functional recovery needs to be confirmed. To guide safe implementation of MIPD, large-scale international randomized trials comparing MIPD and OPD in experienced high-volume centers are needed. We hypothesize that MIPD is non-inferior in terms of overall complications, but superior regarding time to functional recovery, as compared to OPD. Methods/design The DIPLOMA-2 trial is an international randomized controlled, patient-blinded, non-inferiority trial performed in 14 high-volume pancreatic centers in Europe with a minimum annual volume of 30 MIPD and 30 OPD. A total of 288 patients with an indication for elective pancreatoduodenectomy for pre-malignant and malignant disease, eligible for both open and minimally invasive approach, are randomly allocated for MIPD or OPD in a 2:1 ratio. Centers perform either laparoscopic or robot-assisted MIPD based on their surgical expertise. The primary outcome is the Comprehensive Complication Index (CCI®), measuring all complications graded according to the Clavien-Dindo classification up to 90 days after surgery. The sample size is calculated with the following assumptions: 2.5% one-sided significance level (α), 80% power (1-β), expected difference of the mean CCI® score of 0 points between MIPD and OPD, and a non-inferiority margin of 7.5 points. The main secondary outcome is time to functional recovery, which will be analyzed for superiority. Other secondary outcomes include post-operative 90-day Fitbit™ measured activity, operative outcomes (e.g., blood loss, operative time, conversion to open surgery, surgeon-reported outcomes), oncological findings in case of malignancy (e.g., R0-resection rate, time to adjuvant treatment, survival), postoperative outcomes (e.g., clinically relevant complications), healthcare resource utilization (length of stay, readmissions, intensive care stay), quality of life, and costs. Postoperative follow-up is up to 36 months. Discussion The DIPLOMA-2 trial aims to establish the safety of MIPD as the new standard of care for this selected patient population undergoing pancreatoduodenectomy in high-volume centers, ultimately aiming for superior patient recovery. Trial registration ISRCTN27483786. Registered on August 2, 2023

This study investigates the efficacy of the seamless care model in operative management for patients who have undergone laparoscopic Pancreatoduodenectomy, evaluating its potential effects on postoperative quality of life (QOL) and complications. This study encompassed patients who underwent LPD at our institution between February 2022 and May 2023. Patients were randomly allocated to either the standard care group(control group) or the seamless care group(intervention group) using a random number table method. QOL was assessed both preoperatively and postoperatively. The incidence of adverse events before to discharge was evaluated. No significant changes in preoperative QOL measures were seen between the two groups (P > 0.05). Postoperatively, the intervention group exhibited markedly superior physiological function scores and overall quality of life (P < 0.05), as well as a considerably reduced frequency of adverse events (P < 0.05). The intervention group exhibited significantly shorter times to first postoperative flatus and shortened hospital stays relative to the control group (P < 0.05), times to ambulation demonstrated no significant difference (P > 0.05). Seamless care significantly enhances quality of life and reduces adverse events following LPD, warranting its broader clinical implementation.

Background This report describes the authors’ experience with 150 consecutive robotic pancreatoduodenectomies. Methods The study enrolled 150 consecutive patients who underwent robotic pancreatoduodenectomy between 2018 and 2023. Pre- and intraoperative variables such as age, gender, indication, operation time, diagnosis, and tumor size were analyzed. The patients were divided into two groups. Group 1 comprised the first 75 patients, and group 2 comprised the last 75 cases. The median age of the patients was 62.4 years and did not differ between the two groups. Results Morbidity was lower in group 2. The mortality rate was 0.7% at 30 days and 1.3% at 90 days, and there was no difference between the groups. There was a significant reduction ( p  < 0.05) in operative time, resection time, reconstruction time, and conversion to open surgery in group 2. Partial resection of the portal vein was performed in 17 patients and more common in group 2 ( p  < 0.01). The number of resected lymph nodes was higher in group 2. The indication for pancreatoduodenectomy did not differ between the two groups. There was no difference in tumor size or clinical characteristics of the patients. Conclusions The robotic platform is useful for pancreatoduodenectomy, facilitates adequate lymphadenectomy, and is helpful for digestive tract reconstruction after resection. Robotic pancreatoduodenectomy is safe and feasible for selected patients. It should be performed in specialized centers by surgeons experienced in open and minimally invasive pancreatic surgery.

Da Vinci robot-assisted pancreaticoduodenectomy offers advantages, including minimal invasiveness, precise, and safe procedures. This study aimed to investigate the clinical effectiveness of implementing enhanced recovery after surgery (ERAS) concepts in Da Vinci robot-assisted pancreaticoduodenectomy. A retrospective analysis was conducted on clinical data from 62 patients who underwent Da Vinci robot-assisted pancreaticoduodenectomy between January 2018 and December 2022. Among these patients, 30 were managed with ERAS principles, while 32 were managed using traditional perioperative management protocols. Surgical time, intraoperative blood loss, postoperative oral intake time, time to return of bowel function, time to ambulation, visual analog scale (VAS) pain scores, fluid replacement volume, length of hospital stay, total hospital expenses, complications, and patient satisfaction were recorded and compared between the two groups. Postoperative follow-up included assessment of postoperative functional scores, reoperation rates, SF-36 quality of life scores, and survival rates. The average follow-up time was 35.6 months (range: 12–56 months). There were no statistically significant differences in general characteristics, including age, surgical time, intraoperative blood loss, and preoperative medical history between the two groups (P > 0.05). Compared to the control group, the intervention group had an earlier postoperative oral intake time, faster return of bowel function, rapid ambulation, and shorter hospital stays (P < 0.05). The intervention group also had lower postoperative VAS scores, lower fluid replacement volume, lower total hospital expenses, and a lower rate of complications (P < 0.05). Patient satisfaction was higher in the intervention group (P < 0.05). There were no statistically significant differences between the two groups in two-year functional scores, reoperation rates, quality of life scores, and survival rates (P > 0.05). Implementing ERAS principles in Da Vinci robot-assisted pancreaticoduodenectomy substantially expedited postoperative recovery, lowered pain scores, and diminished complications. However, there were no notable differences in long-term outcomes between the two groups.

BackgroundOutcomes of pancreaticojejunostomy without pancreatic duct during open pancreaticoduodenectomy (OPD) are unknown and controversial, and corresponding reports in laparoscopic surgery are lacking.MethodsPatients were evaluated at West China Hospital, and standard laparoscopic pancreaticoduodenectomy (LPD) was planned. A prospective randomized trial was conducted, in which the patients were randomly assigned to the no-stent and internal-stent groups in a single-center trial. The primary outcomes were the incidence of clinically relevant postoperative pancreatic fistula (CR-POPF) and 90-day mortality. Preliminary results were reported.ResultsFrom November 2019 to March 2021, we enrolled 90 patients (41 in the no-stent group and 49 in the internal-stent group) in the study. All baseline parameters of both groups, including age, sex ratio, pancreatic duct diameter, and intraoperative blood loss, were comparable between the two groups except for pathological diagnosis and the texture of remnants. Twenty-seven (65.9%) and 19 (38.8%) patients in the no-stent and internal-stent groups, respectively, had soft pancreatic remnants (P = 0.010). The total incidence of CR-POPF was 5.6% and included two patients (4.9%) in the no-stent group and three patients (6.1%) in the internal-stent group (P = 1.000). Only one patient in the internal-stent group died of heart failure within 90 days after the operation. No significant difference in other postoperative complications was observed between the groups except for biochemical fistula [no-stent group vs. internal-stent group = 31.7% vs. 12.2%, (P = 0.024)].ConclusionsIn a high-volume LPD center, duct-to-mucosa pancreaticojejunostomy without pancreatic duct stent is safe and reliable. In addition, duct-to-mucosa pancreaticojejunostomy without pancreatic duct stent was more challenge. We recommend using the stent during anastomosis and pulling it out after the procedure.

In the recent PORSCH trial, a three-part postpancreatectomy care algorithm was employed with a near 50 ​% reduction in mortality. We hypothesized that clinical care congruent with this protocol would correlate with better outcomes in our patients. Real-world postoperative care was compared to the pathway described by the PORSCH trial and patients were assigned into groups based on congruence with its recommendations. The primary composite outcome (PCO) consisted of 90-day mortality, organ failure, and interventions for bleeding. Of 289 patients, care of 12 ​% was entirely congruent with the PORSCH algorithm. The PCO was recorded in 9 ​% of the PORSCH care group, 8 ​% of the Partial-PORSCH care group, and 19 ​% of the Non-PORSCH care group (p ​= ​0.044). Adverse outcomes were highest when pancreaticoduodenectomy patients received care incongruent with the algorithm's CT imaging recommendations. These results add external validity to the principles of clinical care underlying the PORSCH algorithm. [Display omitted] •Derangements in labwork and vital signs after pancreatectomy warrant investigation.•Early detection and treatment of postpancreatectomy complications improves outcomes.•The PORSCH trial's algorithm may reduce morbidity and mortality in clinical practice.

Background The ideal neoadjuvant treatment protocol for patients with pancreatic cancer (PDAC) remains unclear. We evaluated the efficacy and safety of neoadjuvant hypofractionated chemoradiotherapy with S-1 for patients with resectable (R) and borderline resectable (BR) PDAC. Methods Eligibility criteria included patients with R and BR PDAC, performance status 0–1, and age 20–85 years. Hypofractionated external-beam radiotherapy (30 Gy in 10 fractions) with concurrent S-1 (60 mg/m 2 ) was delivered 5 days/week for 2 weeks prior to pancreatectomy. Results Fifty-seven patients were enrolled in this study, including 33 R and 24 BR [19 BR tumors with portal vein contact (BR-PV) and 5 BR tumors with arterial contact (BR-A)]. The total rates of protocol treatment completion and resection were 91% (50/57) and 96% (55/57), respectively. Seven patients failed to complete S-1 due to cholangitis ( n  = 5) or neutropenia ( n  = 2). The most common grade 3 toxicities [Common Terminology Criteria for Adverse Events (CTCAE) version 4.0] were anorexia (7%), nausea (5%), neutropenia (4%), and leukopenia (4%). No patient experienced grade 4 toxicity. Pathologically negative margins (R0) were achieved in 54 of 55 patients (98%) who underwent pancreatectomy. Pathological response was classified as Evans grade I in 8 patients (15%), IIa in 31 patients (56%), IIb in 14 patients (25%), III in 1 patient (2%), and IV in 1 patient (2%), and operative morbidity (Clavien-Dindo grade IIIb or less) was observed in 4 patients (8%). The 1- and 2-year overall survival (OS) rates were 91 and 83% in R patients, respectively, and 77 and 58% in BR patients, respectively ( p  = 0.03). Conclusion Neoadjuvant S-1 with concurrent hypofractionated radiotherapy is tolerable and appears promising for patients with R and BR PDAC.