GallRiks registry: Twenty years of improving the safety and quality of gallstone surgery and ERCP in Sweden

Abstract

Gallstone disease is common in the Western world, and approximately 15,000 cholecystectomies and 9000 endoscopic retrograde cholangiopancreatographies (ERCPs) are performed each year in Sweden. While being safe, the high frequency of these procedures has a significant cumulative impact on health in the community, exceeding those of many complex procedures for malignant conditions. Compliance with established guidelines for gallstone disease management varies and the strength of supporting evidence remains inconsistent. The Swedish National Register for Gallstone Surgery and ERCP (GallRiks) was launched in May 2005 to monitor outcomes nationwide, to enhance quality of care, and to facilitate population-based research. Continuous feedback to participating units has contributed to improvement in patient care. Since its introduction, laparoscopic procedures have become more prevalent than open cholecystectomies, antibiotic prophylaxis is used more selectively, and the proportion of procedures performed on a day-case basis has increased: all of this despite unchanged healthcare resources. Register-based studies have highlighted the benefits of intraoperative cholangiography, the advantages of centralizing care to high-volume surgeons, endoscopists and units, as well as the impact of surgeon gender on outcomes. Now in its 20th year, GallRiks remains a cornerstone of quality assurance in Swedish gallstone surgery. Research based on register data continues to improve gallstone disease management and shape clinical guidelines and healthcare practice.

Introduction

Gallstone disease is common in the Western world, and approximately 15,000 cholecystectomies and 9,000 endoscopic retrograde cholangiopancreatography (ERCPs) are performed each year in Sweden. ¹ Given the high frequency of these procedures, register data play a crucial role in ensuring surgical safety since even small changes in routines and techniques can have a significant impact on patient outcome. GallRiks, Sweden’s nationwide register for gallstone surgery and ERCP, contributes to improving healthcare by monitoring and ensuring surgical quality, and by facilitating clinical research.

The evolution of GallRiks

In 2005, the National Register for Gallstone Surgery and ERCP was established by the Swedish National Board of Health, the Swedish Society of Laparoscopic Surgery, the Swedish Society of Upper Abdominal Surgery, and the Swedish Surgical Association. The aim was to monitor the quality of care of both cholecystectomies and ERCPs in Sweden. ¹ Within 5 years, nearly all Swedish hospitals had become affiliated to GallRiks. Today, GallRiks covers approximately 95% of all cholecystectomies and 90% of all ERCPs performed in Sweden. This unique database provides unparalleled insight into the surgical quality of Swedish gallstone surgery and ERCP and has contributed to almost 70 scientific publications and 20 doctoral dissertations.

Patient characteristics and intraoperative details are systematically registered in GallRiks, and surgeons and endoscopists record procedure-related data at the time of surgery. Postoperative data, including complications within 30 days, are recorded by local coordinators. Regular six-monthly updates help clinics to compare performance and registration rates. This routine enables hospitals and individual surgeons to assess training progress and procedural volumes.

Annual reports and evidence-based practice

The GallRiks Annual Report describes procedure volumes, coverage, complication rates, and compliance with evidence-based guidelines. In 2023, national guidelines for gallstone disease were introduced under the leadership of the GallRiks steering committee: a demonstration of the register’s role in improving patient care. At annual meetings in Stockholm, current research is presented and challenges in data registration are addressed.

Impact on surgical quality

GallRiks has contributed to significant improvements in gallstone surgery and ERCP outcomes. These include:

• Reduction in antibiotic prophylaxis. Research based on register data demonstrated the lack of benefit of prophylactic antibiotics in elective gallbladder surgery. As a result, antibiotic prophylaxis was gradually reduced leading to lower risk for antibiotic-related complications and antibiotic resistance development.^2,3

• Intraoperative cholangiography (IOC). Data reinforced the importance of IOC in reducing bile duct injury by enhancing anatomical visualization during surgery. ⁴

• The need to treat common bile duct stones. Data have shown the importance of treating common bile duct stones encountered during IOC. ⁵

Innovations and key findings

• Rendezvous ERCP technique. This approach allows for safe bile duct stone removal during surgery, reducing the need for postoperative ERCP and risk for pancreatitis, minimizing patient discomfort, and reducing length of stay in hospital and thereby costs. ⁶

• Volume–outcome relationship. Register data clearly show the correlation between cholecystectomy and ERCP volumes and patient safety, supporting the centralization of gallstone surgery and ERCP to high-volume individuals and centers. ⁷

• Gender and surgical outcomes. An analysis of over 150,000 cholecystectomies found that female surgeons take slightly longer but have lower complication rates and shorter hospital stays. ⁸

GallRiks has also contributed to comparison of surgical techniques by comparing approaches such as “fundus-first” versus standard dissection, demonstrating equivalent outcomes. ⁹

The occurrence of incidental gallbladder cancer is more likely to be diagnosed in older patients, women, and after previous cholecystitis. ¹⁰ A macroscopic selective strategy appears to be the most cost-effective approach to histological assessment of the gallbladder specimen.

Future perspectives

On entering its third decade, GallRiks remains committed to advancing surgical quality through clinically relevant research and register development. A register-based randomized clinical trial is currently evaluating the benefits of interoperative cholangiography in elective laparoscopic cholecystectomy. Furthermore, a disease-specific patient-reported outcome measure has been developed and validated. Data will continue to be routinely collected preoperatively and postoperatively, enabling comprehensive assessment of complications and improvements in quality of life (QOL) following cholecystectomy.

Regional User Tools will be integrated and interactive tables and figures will be available on the GallRiks website https://www.ucr.uu.se/gallriks/. These tools allow various stakeholders, that is, patients, healthcare professionals, researchers, and policymakers, to access and integrate with the register in real time. By providing a user-friendly interface, the register ensures that valuable insights and trends in gallstone surgery and ERCP can be shared by all relevant parties. This increased accessibility will support evidence-based decision-making, foster transparency, and contribute to ongoing improvements in healthcare practice.

The continued success of GallRiks relies on the dedication of coordinators and physicians ensuring accurate comprehensive data collection. These individuals ensure its role as a cornerstone of surgical quality assurance and research in Sweden. The next major improvement will be to evolve the register to support online registration during surgery, ensuring that data are captured accurately and immediately, a practice already adopted by many healthcare units. We anticipate that register data will eventually be automatically extracted from existing digital medical records systems. The integration of artificial intelligence, that records all relevant surgical activities, could play a key role in assessing whether critical safety milestones during procedures have been met. Furthermore, data from preoperative radiological investigations, medical records, and laboratory results, could provide valuable insight into optimal strategies for managing stones in deep bile ducts, thus preventing bile duct injury.