Laparoscopic distal pancreatectomy is more cost-effective than open resection: results from a Swedish randomized controlled trial.

BACKGROUND: Laparoscopic distal pancreatectomy is being implemented worldwide. The aim of this study was to perform a cost-effectiveness analysis from a health care perspective. METHODS: This cost-effectiveness analysis was based on the randomized controlled trial LAPOP, where 60 patients were randomized to open or laparoscopic distal pancreatectomy. For the follow-up of two years, resource use from a health care perspective was recorded, and health-related quality of life was assessed using the EQ-5D-5L. The per-patient mean cost and quality-adjusted life years (QALYs) were compared using nonparametric bootstrapping. RESULTS: Fifty-six patients were included in the analysis. The mean health care costs were lower, €3863 (95% CI: -€8020 to €385), for the laparoscopic group. Postoperative quality of life improved with laparoscopic resection and resulted in a gain in QALYs of 0.08 (95% CI: -0.09 to 0.25). The laparoscopic group had lower costs and improved QALYs in 79% of bootstrap samples. With a cost-per-QALY threshold of €50 000, 95.4% of the bootstrap samples were in favour of laparoscopic resection. CONCLUSION: Laparoscopic distal pancreatectomy is associated with numerically lower health care costs and improvements in QALYs compared with the open approach. The results support the ongoing transition from open to laparoscopic distal pancreatectomies.

Quality of life after open versus laparoscopic distal pancreatectomy: long-term results from a randomized clinical trial.

BACKGROUND: Pancreatic surgery is rapidly transitioning towards minimally invasive methods. Positive results have been published regarding the safety and efficacy of laparoscopic distal pancreatectomy, but postoperative quality of life after operation remains relatively unexplored. The aim of this study was to assess the long-term quality of life after open versus laparoscopic distal pancreatectomy. METHODS: A long-term analysis of quality-of-life data after laparoscopic and open distal pancreatectomy based on the LAPOP trial (a single-centre, superiority, parallel, open-label, RCT in which patients undergoing distal pancreatectomy were randomized 1 : 1 to either the open or laparoscopic approach). Patients received the quality-of-life questionnaires QLQ-C30 and PAN26 before surgery and at 5-6 weeks, 6 months, 12 months, and 24 months after surgery. RESULTS: Between September 2015 and February 2019, a total of 60 patients were randomized, and 54 patients (26 in the open group and 28 in the laparoscopic group) were included in the quality-of-life analysis. A significant difference was observed in six domains in the mixed model analysis, with better results among patients who underwent laparoscopic surgery. At the 2-year measurement, a statistically significant difference between groups was seen in three domains, and a clinically relevant difference of 10 or more was seen in 16 domains, with better results among the patients who underwent laparoscopic resection. CONCLUSION: Considerable differences were shown in postoperative quality of life after laparoscopic compared with open distal pancreatectomy, with better results among the patients who had undergone laparoscopic resection. Of note, some of these differences persisted up to 2 years after surgery. These results strengthen the ongoing transition from open to minimally invasive pancreatic surgery for distal pancreatectomy. Registration number: ISRCTN26912858 (http://www.controlled-trials.com).

Symptoms and life changes after total pancreatectomy: a qualitative study.

BACKGROUND: Total pancreatectomy (TP) is a major surgical procedure that involves lifelong exocrine and endocrine pancreatic insufficiency. Qualitative evidence is sparse regarding patients' experiences after the operation. The aim of this study was to explore patients' experiences of symptoms that occur after TP and how these symptoms affect their health and life situations. METHODS: A qualitative design with prospective consecutive sampling and an inductive thematic analysis was used. Semistructured interviews were postoperatively performed at 6-9 months with 20 patients undergoing TP in two university hospitals in Sweden. RESULTS: Two main themes emerged from the analysis: "Changes in everyday life" and "Psychological journey". Patients experienced symptoms related to diabetes as the major life change after the operation, and they were also limited by symptoms of exocrine insufficiency, difficulties with food intake and physical weakness. In the psychological journey that patients underwent, the support received from family, friends and the health care system was important. Moreover, patients experienced a general need for more extensive information, especially regarding diabetes. CONCLUSION: Patients experience a lack of sufficient support and education after TP, particularly concerning their diabetes. Further efforts should be undertaken to improve information and the organization of diabetes care for this patient group.

Complications and chemotherapy have little impact on postoperative quality of life after pancreaticoduodenectomy - a cohort study.

BACKGROUND: With the poor prognosis of pancreatic cancer and the high rate of postoperative complications after pancreaticoduodenectomy, it is important to evaluate how the operation affects patients' quality of life. METHODS: This single-centre study included all patients undergoing pancreaticoduodenectomy from 2006 to 2016. Quality of life was measured with two questionnaires preoperatively, and at 6 and 12 months postoperatively. Comparisons between groups were made using a linear mixed models analysis. RESULTS: Of 279 patients planned for pancreaticoduodenectomy, 245 underwent the operation. The postoperative response rates were all 80% or more. Differences were found in one domain between the early and late time periods and three domains between patients receiving and not receiving adjuvant chemotherapy. No significant differences were found between patients with and without severe postoperative complications. However, the demographic variables of age group, sex, preoperative diabetes and smoking all exerted a significant impact on postoperative quality of life. CONCLUSION: While little or no impact was shown for the factors of postoperative complications, time period and adjuvant chemotherapy, demographic data, such as age, sex, preoperative diabetes and smoking, had considerable impacts on postoperative quality of life after pancreaticoduodenectomy.

Malignancy in elective cholecystectomy due to gallbladder polyps or thickened gallbladder wall: a single-centre experience.

INTRODUCTION: Gallbladder cancer is a rare but aggressive malignancy. Surgical resection is recommended for gallbladder polyps ≥10 mm. For gallbladder wall thickening, resection is recommended if malignancy cannot be excluded. The incidence of gallbladder malignancy after cholecystectomy with indications of polyps or wall thickening in the Swedish population is not known. MATERIAL/METHODS: A retrospective study was performed at Linköping University Hospital and included patients who underwent cholecystectomy 2010 - 2018. All cholecystectomies performed due to gallbladder polyps or gallbladder wall thickening without other preoperative malignant signs were identified. Preoperative radiological examinations were re-analysed by a single radiologist. Medical records and histopathology reports were analysed. RESULTS: In all, 102 patients were included, of whom 65 were diagnosed with gallbladder polyps and 37 with gallbladder wall thickening. In each group, one patient (1.5% and 2.7% in each group) had gallbladder malignancy ≥ pT1b.Two (3.1%) and three (8.1%) patients with gallbladder malignancy < T1b were identified in each group. DISCUSSION/CONCLUSION: This study indicates that the incidence of malignancy is low without other malignant signs beyond gallbladder polyps and/or gallbladder wall thickening. We propose that these patients should be discussed at a multidisciplinary tumour board. If the polyp is 10-15 mm or if the gallbladder wall is thickened but no other malignant signs are observed, cholecystectomy can be safely performed by an experienced general surgeon at a general surgery unit. If the histopathology indicates ≥ pT1b, the patient should be referred immediately to a hepatobiliary centre for liver and lymph node resection.

Preoperative Biliary Drainage Does Not Independently Reduce Survival After Pancreaticoduodenectomy Among Patients With Pancreatic Ductal Adenocarcinoma: A National Registry Study.

Objective: This study aimed to explore a possible relationship between preoperative biliary drainage (PBD) and overall survival in a national cohort of Swedish patients who underwent pancreaticoduodenectomy (PD) for pancreatic ductal adenocarcinoma (PDAC). Background: PBD has been shown to increase postoperative complications after PD, but its use is steadily increasing. There are a few small studies that have indicated that PBD might in itself negatively affect overall survival after PD. Methods: Patients from the Swedish National Registry for tumors in the pancreatic and periampullary region diagnosed from 2010 to 2019 who underwent PD for PDAC were included. Kaplan-Meier curves, log-rank tests and Cox proportional hazards analyses were performed to investigate survival. Results: Out of 15,818 patients in the registry, 3113 had undergone PD, of whom 1471 had a histopathological diagnosis of PDAC. Patients who had undergone PBD had significantly worse survival, but the effect of PBD disappeared in the multivariable analysis when elevated bilirubin at any time was included. Conclusions: PBD does not independently influence survival after PD for PDAC, but this study implies that even a nominally increased preoperative bilirubin level might impair long-term survival.

A risk score model to predict incidental gallbladder cancer in patients scheduled for cholecystectomy.

BACKGROUND: Gallbladder cancer (GBC) has a poor prognosis. The aim was to develop and validate a preoperative risk score for incidental gallbladder cancer (IGBC) in patients scheduled for cholecystectomy. METHODS: Data registered in the nationwide Swedish Registry for Gallstone Surgery (GallRiks) was analyzed, including the derivation cohort (n = 28915, 2007-2014) and the validation cohort (n = 7851, 2014-2016). An additive risk score model based on odds ratio was created. RESULTS: The scoring model to predict IGBC includes age, female gender, previous cholecystitis, and either jaundice or acute cholecystitis. The calibration by HL test and discrimination by AUROC was 8.27 (P = 0.291) and 0.76 in the derivation cohort (214 IGBC) and 14.28 (P = 0.027) and 0.79 in the validation cohort (35 IGBC). The scoring system was applied to three risk-groups, based on the risk of having IGBC, eg. the high-risk group (>8 points) included 7878 patients, with 154 observed and 148 expected IGBC cases. CONCLUSION: We present the first risk score model to predict IGBC. The model estimates the expected risk for the individual patient and may help to optimize treatment strategies.

There Is No Increase in Perioperative Mortality After Pancreaticoduodenectomy in Octogenarians: Results From the Swedish National Registry for Tumors in the Pancreatic and Periampullary Region.

Objective: The aim of this observational study was to compare postoperative mortality and complications between octogenarians and younger patients following pancreaticoduodenectomy (PD). Summary Background Data: With the growing elderly population and improved operative and postoperative results, PD is performed more frequently in octogenarians. Despite recent studies, it is uncertain whether elderly patients experience worse postoperative outcomes than younger patients. Methods: All patients registered in the Swedish National Registry for tumors in the pancreatic and periampullary region from 2010 to 2018 who underwent PD were included in the analysis. Results: Out of 13,936 patients included in the registry, 2793 patients underwent PD and were divided into the following age groups: <70 (n = 1508), 70-79 (n = 1137), and ≥80 (n = 148) years old. There was no significant difference in in-hospital, 30- or 90-day mortality among groups. The 2 older groups had a higher rate of medical and some surgical complications but not a significantly higher rate of complications ≥IIIa according to the Clavien-Dindo classification system. The 2 older groups had lower body mass index, higher American Society of Anesthesiologists and Eastern Cooperative Oncology Group scores, lower smoking rates, and a higher rate of preoperative biliary drainage than the <70-year-old group (all P < 0.001). The operation time was shorter in the oldest group. Conclusions: Despite the worse preoperative condition of octogenarians than younger patients, short-term mortality and serious complications were not increased. The shorter operation time, however, may indicate that patients in the oldest group were more strictly selected. With careful preoperative consideration, especially regarding cardiovascular morbidity, more octogenarians can potentially be safely offered PD.

Incidental metastases and lymphoma of the gallbladder - an analysis of ten rare cases identified from a large national database.

Background: The aim was to identify and characterize rare malignancies of the gallbladder, incidentally found at cholecystectomy, and describe the diagnostic work-up, treatment and outcome. Methods: Data from cholecystectomies during 2007-2014 registered in the Swedish Register for Gallstone Surgery (GallRiks) were analyzed for incidental cancer. For completion of the pathology report, data were linked with the Swedish Registry for Cancer in the liver and biliary tract (SweLiv) and/or the Swedish Cancer Registry. Results: From 36,355 patients that underwent cholecystectomy on a benign indication 215 cases of incidental gallbladder cancer (IGBC) were identified. In total seven patients with metastases to the gallbladder from different primary tumors (breast cancer, malignant melanoma, gastric cancer, renal cell carcinoma, upper gastrointestinal cancer, colon cancer and pancreatic cancer) and three patients with lymphoma involvement of the gallbladder were found. Most patients were female with no difference between the groups (8/10 versus 171/215). The median age for the metastasis and lymphoma (MOL) group was equal to the IGBC group, 70 (64-72) years versus 70 (63-78) years. All patients in the MOL group underwent preoperative imaging with ultrasound or computed tomography, on which no metastases were identified. In only two patients a tumor was seen by the surgeon during the perioperative examination of the gallbladder. The median survival was 5.8 months for MOL patients and 23 months for IGBC patients. Conclusion: Metastases and lymphoma of the gallbladder are rare. Traditional imaging methods prior to cholecystectomy may miss gallbladder malignancies. A liberal approach of histopathological analysis of the gallbladder should be applied.

Are Incidental Gallbladder Cancers Missed with a Selective Approach of Gallbladder Histology at Cholecystectomy?

BACKGROUND: Incidental gallbladder cancer (IGBC) is an unexpected finding when a cholecystectomy is performed upon a benign indication, and the use of routine or selective histological analysis of gallbladder specimen is still debated. The aim of this study was to investigate whether the proportion of submitted gallbladder specimens for pathological investigation influences the proportion of IGBC found, and what possible factors preoperatively or perioperatively could influence the selection process. METHODS: All cholecystectomies between January 2007 and September 2014 registered in the Swedish Registry of Gallstone Surgery and ERCP (GallRiks) were included. Proportion of histological analysis was divided into four subgroups (0-25%, >25-50%, >50-75%, >75-100%). RESULTS: A total of 81,349 cholecystectomies were registered, and 36,010 (44.3%) gallbladder specimens were sent for histological analysis. A total of 213 cases of IGBC were discovered, which constituted 0.26% of all cholecystectomies performed and 0.59% of the number of gallbladder specimens sent for histological analysis. Hospitals submitting >75-100% of the gallbladder specimens had significantly more IGBC/1000 cholecystectomies performed (p = 0.003). Hospitals with the most selective approach had a significantly higher proportion of IGBC/1000 gallbladders that were sent for histological analysis (p < 0.001). Factors such as higher age (p < 0.001), female gender (p = 0.048) and macroscopic cholecystitis (p < 0.001) were more common in gallbladder specimens from hospitals that had a selective approach to histological analysis. CONCLUSION: A routine approach to histological analysis in cholecystectomies with a benign indication for surgery can uncover a higher proportion of IGBC cases. When a selective approach is used, risk factors should be taken into account.

Predictors of incidental gallbladder cancer in patients undergoing cholecystectomy for benign gallbladder disease: Results from a population-based gallstone surgery registry.

BACKGROUND: Gallbladder cancer is a rare neoplasm with a poor prognosis. Early diagnosis and correct treatment strategy is important. The aim of this study was to identify predictors for incidental gallbladder cancer. METHODS: Data from cholecystectomies registered in the nationwide Swedish Register for Gallstone Surgery between 2007 and 2014 were analyzed for incidental gallbladder cancer. Exclusion criteria were patients with a gallbladder not sent for histopathology, preoperative suspicion of polyps/gallbladder cancer, and indication for operation for other reasons than gallstone disease. Predictive factors for incidental gallbladder cancer were identified using multivariable logistic regression. RESULTS: A total of 86,154 procedures were registered in the Swedish Register for Gallstone Surgery. Of these, 36,355 patients were included in the analysis, and 215 of the included patients had incidental gallbladder cancer (0.59%). Mean age was 70 ± 11 years for index cases and 54 ± 16 years for the control group, and 80% of cases and 60% of controls were female. Predictors for incidental gallbladder cancer were older age (odds ratio = 1.08; P < .001), female sex (odds ratio = 3.58; P < .001), previous cholecystitis (odds ratio = 1.37; P = .045), and the combination of acute cholecystitis without jaundice (odds ratio = 1.39; P = .041) and jaundice without acute cholecystitis (odds ratio = 2.02; P = .009). A preoperative risk model including these factors gave an area under receiver operating characteristic curve of 0.82. By adding macroscopic evaluation of the gallbladder by the surgeon, the area under receiver operating characteristic curve increased to 0.87. Intraoperatively suspected gallbladder cancer was confirmed as cancer in 31% of the cases. CONCLUSION: Incidental gallbladder cancer is more likely to be diagnosed in older patients, women, and after previous cholecystitis. Jaundice and acute cholecystitis were also shown to be important risk factors. Intraoperative inspection of the gallbladder improved the risk model.

Surgical treatment for gallbladder cancer - a systematic literature review.

OBJECTIVE: To evaluate existing evidence regarding surgical treatments for gallbladder cancer in a Health Technology Assessment. A specific aim was to evaluate whether extended surgery regarding liver, lymph nodes, bile duct, and adjacent organs compared with cholecystectomy alone in the adult patient with gallbladder cancer in early and late stages implies improved survival. METHODS: In April 2015 and updated in June 2016, a systematic literature search was conducted in PubMed, Embase, and the Cochrane Library. Two authors independently screened titles, abstracts, and full-text articles. The certainty of evidence was evaluated according to GRADE. MAIN RESULTS: Forty-four observational studies (non-randomised, controlled studies) and seven case series were included. Radical resection, including liver and lymph node resection, compared with cholecystectomy alone showed significantly better survival for patients with stages T1b and above. All studies had serious study limitations and the certainty of evidence was very low (GRADE ⊕○○○). A survival benefit seen in patients with stage T1b or higher with lymph node resection, was most evident in stage T2, but the certainty of evidence was low (GRADE ⊕⊕○○). It is uncertain whether routine bile duct resections improve overall survival in patients with gallbladder cancer stage T2-T4 (GRADE ⊕○○○). CONCLUSION: Data indicate that prognosis can be improved if liver resection and lymph node resection is performed in patients with tumour stage T1b or higher. There is no evidence supporting resection of the bile duct or adjacent organs if it is not necessary in order to achieve radicality.