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.

Disparities in the regional, hospital and individual levels of antibiotic use in gallstone surgery in Sweden.

BACKGROUND: Antimicrobial resistance may be promoted by divergent routines and lack of conformity in antibiotic treatment, especially regarding the practice of antibiotic prophylaxis. The aim of the present study was to assess differences in gallstone surgery regarding antibiotic use in Sweden. METHODS: The study was based on data from the Swedish Register for Gallstone Surgery and ERCP (GallRiks) 2005-2015. Funnel plots were used to test impact of grouping factors, including, hospital and surgeon and to identify units that deviated from the rest of the population. RESULTS: After adjusting for cofounders including age, gender, ASA classification, indication for surgery, operation time, gallbladder perforation and emergency status, there were 0/21 (0%) at the regional level, 18/76 (24%) at the hospital level and 128/1038 (12%) at the surgeon level outside the 99.9% confidence interval (CI). The estimated median odds ratios were 1.13 (95% CI 1.00-1.31) at the regional level, 1.93 (95% CI 1.70-2.19) at the hospital level and 2.38 (95% CI 2.26-2.50) at the surgeon level. CONCLUSION: There are significant differences between hospitals and surgeons, but little or no differences between regions. These deviations confirm the lack of standardization in regards to prescription of antibiotic prophylaxis and the need more uniform routines regarding antibiotic usage. Randomized controlled trials and large population-based studies are necessary to assess assessing the effectiveness and safety of antibiotic prophylaxis in gallstone surgery.

The role of antibiotic prophylaxis in routine endoscopic retrograde cholangiopancreatography investigations as assessed prospectively in a nationwide study cohort.

OBJECTIVE: Risk factors for complications after endoscopic retrograde cholangiopancreatography (ERCP) with emphasis on the potential advantage of the use of prophylactic antibiotics were studied in a national population-based study cohort. MATERIALS AND METHODS: All ERCP procedures registered in the Swedish Registry of Gallstone Surgery and ERCP (GallRiks) between May 2005 and June 2013 were analyzed. Patients with ongoing antibiotic treatment, incomplete registration or those who had not undergone an index ERCP were excluded. Risk factors for adverse events were analyzed. RESULTS: Data from 47,950 ERCPs were collected, but after applying the exclusion criteria, 31,188 examinations were analyzed. In the group receiving prophylactic antibiotics, the postoperative adverse event rate was 11.6% compared with 14.2% in the group without antibiotics. The odds ratio (OR) for the risk of postoperative adverse events in patients receiving prophylactic antibiotics was 0.74 (95% confidence interval [CI]: 0.69-0.79). When analyzing a subgroup of 21,893 ERCPs for the three most common indications (common bile duct stones, malignancy, and obstructive jaundice), the beneficial effect of prophylactic antibiotics on adverse events remained (OR = 0.76; 95% CI: 0.70-0.82). Further, in the subgroup of patients with obstructive jaundice, the administration of prophylactic antibiotics had a beneficial effect on septic complications (OR = 0.76; 95% CI: 0.58-0.97). CONCLUSION: The risk of adverse events after ERCP is reduced 26% if antibiotics are given prophylactically during ERCP investigations, as suggested by data gained from this national population-based study. However, in absolute terms, the reduction in adverse events by prophylactic antibiotics is modest (2.6%).

[GallRiks 10 years. Quality registry for gallstone surgery have improved health care]. / GallRiks 10 år - Kvalitetsregister för gallstens-kirurgi har förbättrat vården.

The Swedish Registry for cholecystectomy and endoscopic retrograde cholangiopancreatography (ERCP) (GallRiks) is a validated register with high coverage. The registry started on May 1, 2005 and serves as a base for audit on gallstone disease treatment and also provides a database for clinical research. The aim of this study is to present an overview of the clinical consequences and implementations in patient care that GallRiks research may have contributed to during a 10-year period. Results from studies on GallRiks data have reduced the use of antibiotic and thromboembolic prophylaxis as well as showed the importance of intraoperative cholangiography. Furthermore, the studies on GallRiks data have most probably changed the treatment strategies in ERCP. Studies on GallRiks data have changed and improved the management of patients in Sweden who undergo gallstone surgery or ERCP.

Natural course vs interventions to clear common bile duct stones: data from the Swedish Registry for Gallstone Surgery and Endoscopic Retrograde Cholangiopancreatography (GallRiks).

IMPORTANCE: The optimal strategy for common bile duct stones (CBDSs) encountered during cholecystectomy is yet to be determined. OBJECTIVE: To evaluate the outcomes after various interventional techniques to clear the bile ducts and the natural course of CBDSs found during intraoperative cholangiography. DESIGN, SETTING, AND PARTICIPANTS: In a large retrospective cohort analysis, we analyzed data from the Swedish Registry for Gallstone Surgery and Endoscopic Retrograde Cholangiopancreatography (GallRiks). We included all patients with CBDSs found on intraoperative cholangiography during cholecystectomy from May 1, 2005, through December 31, 2009. EXPOSURES: Presence of CBDSs on intraoperative cholangiography. MAIN OUTCOMES AND MEASURES: Relation between strategies for handling CBDSs in terms of complication rates and/or incomplete clearance with need of intervention (ie, unfavorable outcomes). RESULTS: In 38,864 cholecystectomies, CBDSs were found in 3969 patients, of whom 3828 underwent analysis. Earlier or ongoing symptoms were more common with increasing stone size (P < .001). In total, postoperative unfavorable outcomes were found in 14.9% but less frequently for patients with smaller stones (P < .01). Among patients in whom no intraoperative measures were taken (representing natural course), the risk for unfavorable outcomes was 25.3%. This risk was significantly lower in patients in whom any measure was taken to clear the ducts (12.7%; odds ratio, 0.44 [95% CI, 0.35-0.55]). The same was found when small (<4 mm) and medium (4-8 mm) stones were analyzed separately (odds ratio, 0.52 [95% CI, 0.34-0.79] and 0.24 [95% CI, 0.17-0.32], respectively). CONCLUSIONS AND RELEVANCE: The high rates of unfavorable outcomes associated with taking no measures when CBDSs are found during cholecystectomy suggest that the natural course might not be as favorable as earlier suggested. This finding implies that, in general, efforts should be made to clear the bile ducts.

Rendezvous cannulation technique reduces post-ERCP pancreatitis: a prospective nationwide study of 12,718 ERCP procedures.

OBJECTIVES: The aim of this study was to investigate if intraoperative rendezvous cannulation reduces the risk of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) because there is no universal consensus on the optimal treatment of common bile duct stones. METHODS: We performed a nationwide case-control study, nested within the cohort of ERCP procedures reported to the Swedish Registry for Gallstone Surgery and ERCP (GallRiks), between 2007 and 2009. Data were collected prospectively from a web-based registry of ERCP procedures that includes variables such as patient characteristics, indication, cannulation technique, diagnostic findings, therapeutic measures, and complications. The primary outcome was PEP. RESULTS: The registry included 12,718 ERCP procedures performed on patients without a history of previous ERCP. The risk of PEP when using the rendezvous technique compared with those who were cannulated by conventional means was reduced from 3.6 to 2.2% (odds ratio (OR) 0.5, 95% confidence interval 0.2-0.9, P=0.02). Although a significant reduction there are overall relatively few cases with PEP and the calculated numbers needed to treat to avoid one case of PEP is as high as 71. Other factors associated with increased risk of PEP were young age, prolonged procedure time, and elective ERCP. CONCLUSIONS: Rendezvous bile duct cannulation during ERCP reduces the risk of PEP from 3.6 to 2.2% compared with conventional biliary cannulation.

The Swedish Registry of Gallstone Surgery and Endoscopic Retrograde Cholangiopancreatography (GallRiks): A nationwide registry for quality assurance of gallstone surgery.

OBJECTIVES: To describe the process of initiating and organizing a nationwide validated web-based quality registry of gallstone surgery and endoscopic retrograde cholangiopancreatography (ERCP) and to present some clinical data and the impact the registry has had on the clinical treatment of gallstones. DESIGN: Observational, population-based registry study. SETTING: Data from the nationwide Swedish Registry of Gallstone Surgery and ERCP (GallRiks). PATIENTS: From May 1, 2005, to December 31, 2011, 63 685 cholecystectomies (laparoscopic and open) and 37 860 ERCPs have been prospectively registered in GallRiks. INTERVENTIONS: Cholecystectomies, laparoscopic or conventional, as well as ERCP in a population-based setting. MAIN OUTCOME MEASURES: Registrations of all cholecystectomies and ERCPs are performed online by the surgeon or endoscopist. Thirty-day follow-up of both gallstone surgery and ERCP is mandatory, as is an additional 6-month follow-up of the cholecystectomies. Scores on the 36-Item Short Form Health Survey are registered preoperatively and 6 months postoperatively in elective cholecystectomies at selected units. RESULTS: The 30-day overall complication rate is 6.1% in elective cholecystectomy, 11.2% in urgent cholecystectomy, and 12.0% following ERCP. The use of antibiotic and thromboembolic prophylaxis in elective laparoscopic cholecystectomy in Sweden has decreased by 8.7% and 17.8% (2006-2011), respectively, mainly owing to presentation of GallRiks data both at meetings and published in peer-reviewed publications. The large database has also enabled several research projects, including one demonstrating that the intention to perform intraoperative cholangiography reduced the risk of death after cholecystectomy. The database has reached greater than 90% national coverage and is continuously validated. CONCLUSIONS: GallRiks is a validated national quality registry for gallstone surgery and ERCP, serving as a base for audit of gallstone disease treatment. It also provides a database for clinical research.

Effect of intended intraoperative cholangiography and early detection of bile duct injury on survival after cholecystectomy: population based cohort study.

OBJECTIVES: To determine whether the routine use of intraoperative cholangiography can improve survival from complications related to bile duct injuries. DESIGN: Population based cohort study. SETTING: Prospectively collected data from the Swedish national registry of gallstone surgery and endoscopic retrograde cholangiopancreatography, GallRiks. Multivariate analysis done by Cox regression. POPULATION: All cholecystectomies recorded in GallRiks between 1 May 2005 and 31 December 2010. MAIN OUTCOME MEASURES: Evidence of bile duct injury, rate of intended use of intraoperative cholangiography, and rate of survival after cholecytectomy. RESULTS: During the study, 51,041 cholecystectomies were registered in GallRiks and 747 (1.5%) iatrogenic bile duct injuries identified. Patients with bile duct injuries had an impaired survival compared with those without injury (mortality at one year 3.9% v 1.1%). Kaplan-Meier analysis showed that early detection of a bile duct injury, during the primary operation, improved survival. The intention to use intraoperative cholangiography reduced the risk of death after cholecystectomy by 62% (hazard ratio 0.38 (95% confidence interval 0.31 to 0.46)). CONCLUSIONS: The high incidence of bile duct injury recorded is probably from GallRiks' ability to detect the entire range of injury severities, from minor ductal lesions to complete transections of major ducts. Patients with bile duct injury during cholecystectomy had impaired survival, and early detection of the injury improved survival. The intention to perform an intraoperative cholangiography reduced the risk of death after cholecystectomy.

Covered versus uncovered self-expandable nitinol stents in the palliative treatment of malignant distal biliary obstruction: results from a randomized, multicenter study.

BACKGROUND: Covered biliary metal stents have been developed to prevent tumor ingrowth. Previous comparative studies are limited and often include few patients. OBJECTIVE: To compare differences in stent patency, patient survival, and complication rates between covered and uncovered nitinol stents in patients with malignant biliary obstruction. DESIGN: Randomized, multicenter trial conducted between January 2006 and October 2008. SETTING: Ten sites serving a total catchment area of approximately 2.8 million inhabitants. PATIENTS: A total of 400 patients with unresectable distal malignant biliary obstruction. INTERVENTIONS: ERCP with insertion of covered or uncovered metal stent. Follow-up conducted monthly for symptoms indicating stent obstruction. MAIN OUTCOME MEASUREMENTS: Time to stent failure, survival time, and complication rate. RESULTS: The patient survival times were 116 days (interquartile range 242 days) and 174 days (interquartile range 284 days) in the covered and uncovered stent groups, respectively (P = .320). The first quartile stent patency time was 154 days in the covered stent group and 199 days in the uncovered stent group (P = .326). There was no difference in the incidence of pancreatitis or cholecystitis between the 2 groups. Stent migration occurred in 6 patients (3%) in the covered group and in no patients in the uncovered group (P = .030). LIMITATIONS: Randomization was not blinded. CONCLUSIONS: There were no significant differences in stent patency time, patient survival time, or complication rates between covered and uncovered nitinol metal stents in the palliative treatment of malignant distal biliary obstruction. However, covered stents migrated significantly more often compared with uncovered stents, and tumor ingrowth was more frequent in uncovered stents.

Nationwide, population-based data from 11,074 ERCP procedures from the Swedish Registry for Gallstone Surgery and ERCP.

BACKGROUND: The Swedish Registry for Gallstone Surgery and ERCP (GallRiks) is the first nationwide Web-based quality registry for gallstone surgery and ERCP in the world. In this article we report data from 11,074 ERCPs performed in 2007 and 2008. OBJECTIVE: The aim of this study is to present outcomes, safety data, and success rates of ERCPs performed in Sweden. DESIGN: Data gathering from a medical record database. PATIENTS: This study reviewed 11,074 ERCPs performed in 2007 and 2008. METHODS: In GallRiks, data concerning surgery performed for gallstone disease as well as all ERCPs are recorded. The registry is approved by the Swedish Surgical Society and is based on an Internet platform with online data registration. The online program includes 30-day follow-up information as well as the opportunity to retrieve electronic reports on demand. The present data represent 76% of all ERCPs performed in Sweden in 2007 and 95% of those performed in 2008. The database also has been validated, indicating a complete match between the medical records and the database in 97.3% of ERCP cases. MAIN OUTCOME MEASUREMENTS: Cannulation success and perioperative and postoperative complications. RESULTS: A successful bile duct cannulation was achieved in 92% of the ERCPs performed. The presence of common bile duct stones was the predominant finding and was seen in 36.8% of examinations. Perioperative and postoperative complication rates were 2.5% and 9.8%, respectively. The rate of ERCP-induced pancreatitis was 2.7%, and the total 30-day mortality rate in the database was 5.9% but varied significantly among the different diagnostic groups. The indications for ERCP differed between high-volume and low-volume centers, indicating an adequate referral pattern of complex cases in Sweden. LIMITATIONS: GallRiks registration is voluntary and thus not 100%. This makes selection bias a possibility. CONCLUSION: ERCP is widely used at Swedish hospitals, with acceptable cannulation success rates and perioperative and postoperative complication rates similar to established standards. GallRiks is a population-based nationwide registry with good data validity and high inclusion rates regarding ERCPs.

Effectiveness of prophylactic antibiotics in a population-based cohort of patients undergoing planned cholecystectomy.

BACKGROUND: In the absence of randomized controlled trials with sufficient power to assess the effectiveness of prophylactic antibiotics (PA), the best evidence is provided by large population-based register studies. METHODS: The Swedish Register of Gallstone Surgery and ERCP (GallRiks) started in May 2005 and reached 75% national coverage in 2007. During 2006 and 2007, a total of 16,400 operations were registered in GallRiks. In the present study, all elective procedures performed in 2006-2007 in units performing at least 25 operations annually were included in an analysis of the risk for postoperative infectious complications RESULTS: Altogether 10,927 procedures were performed 2006-2007. Univariate logistic regression analysis revealed a paradoxical increase in postoperative infectious complications requiring antibiotic treatment and postoperative abscess if PA were given (p < 0.05). This increase disappeared in multivariate analysis with adjustment for age, gender, presence of cholecystitis, accidental gallbladder perforation, and presence of bile duct stones. CONCLUSION: No benefit from PA was seen in this study on elective cholecystectomy. Although a randomized controlled trial could possibly show a reduction in the risk for postoperative infectious complications not detected in this study, such a reduction must be weighed against the risk of promoting drug resistance by the widespread use of PA.

Surgical treatment of gallstones: changes in a defined population during a 20-year period.

OBJECTIVE: To study developments in routine gallstone surgery in a defined population over a 20-year period with regard to incidence of operations, implementation of new methods, postoperative complications, and postoperative duration of hospital stay. DESIGN: Retrospective study of medical records. SETTING: County hospital, Sweden. SUBJECTS: All patients who were residents of Jönköping during one of the three-year periods 1976-1978, 1986-1988, or 1996-1998 and had their first surgical treatment, either cholecystectomy/choledochotomy or therapeutic endoscopy for gallstone disease. RESULTS: The overall annual incidence of operations for gallstones decreased from 2.01 to 1.13/1000 inhabitants between the first and second period (p < 0.001). This is explained by a significant reduction in the number of elective operations while the number of urgent operations increased between the first and second periods from 0.39 to 0.53/1000 (p < 0.05) and continued to increase and reached 0.75/1000 during the third period (p < 0.001). New methods were introduced for the treatment of gallstones that gradually made this type of operation more varied and complex in routine practice. The postoperative hospital stay decreased from 7.0 days during the 1970s to 3.9 days during the 1990s. Postoperative morbidity was unchanged. CONCLUSIONS: The decreasing rate of gallstone surgery noted between the 1970s and 1980s did not continue through the 1990s. Urgent surgery for gallstone disease has gradually become more common and now predominates over elective surgery in routine practice. The introduction of less traumatic surgical techniques contributed to the significant decrease in hospital stay after gallstone surgery. However, morbidity has not decreased and the diversification of surgical techniques used for treatment of gallstones requires continuous evaluation in routine practice.