A new study from researchers in Minnesota found that endoscopic retrograde cholangiopancreatography (ERCP) performed in a community hospital setting results in complication rates that compare favorably with those of academic centers while achieving technical success at or above the performance levels recommended by the American Society for Gastrointestinal Endoscopy (ASGE)/American College of Gastroenterology (ACG) Task Force. This is the first large study evaluating complications and quality indicators in a purely non-academic community practice. The study appears in the September issue of GIE: Gastrointestinal Endoscopy, the monthly peer-reviewed scientific journal of the American Society for Gastrointestinal Endoscopy.
ERCP is a specialized technique used to study and treat problems of the ducts that drain the liver and pancreas. To reach the ducts, an endoscope is passed through the mouth, past the stomach and into the small intestine (duodenum). A thin tube is then inserted through the endoscope into the common bile duct and pancreatic duct connecting the liver and pancreas to the intestine. A contrast material (dye) is injected through the tube outlining those ducts while X-rays are being taken. The X-rays can show narrowing or blockages in the ducts that may be due to a cancer, gallstones or other abnormalities.
ERCP is technically challenging and is associated with the highest rate of complications among gastroenterological procedures. Because of the attendant risk of ERCP, cases that portend to be more complex are likely to be managed in academic medical centers. Therefore, much of the data regarding complications has been published from academic institutions. Rates of complications have not been well studied in community-based gastroenterology practices.
"This was a prospective study to determine the outcomes and complications of ERCP in a community practice using seven of the eight quality indicators outlined by ASGE, with particular attention to the 30-day complication rate," said study lead author Joshua B. Colton, MD, Minnesota Gastroenterology PA, Maplewood, Minn. "We found that the complication rate was five percent in this community practice, which is very favorable as we know that large ERCP studies from academic centers have documented complication rates of five to 15.9 percent. In addition, our success rates met or exceeded the recommended rates reported by the ASGE/ACG Task Force."
The 2006 ASGE/ACG Task Force on Quality in Endoscopy proposed 11 research questions, with five of the questions specifically directed at ERCP in the community setting. In 2002, the ASGE Committee on Outcomes Research published eight ERCP-specific quality indicators designed to provide a more complete description of quality in ERCP. The aim of this prospective study was to determine ERCP quality outcomes, including complications, in a community practice using these quality indicators.
The study was performed from December 1, 2005, through July 31, 2006, at eight community hospitals in Minneapolis, St. Paul and surrounding suburbs in Minnesota. Diagnositic and therapeutic ERCP procedures in both inpatients and outpatients were included. A total of 805 ERCP procedures were performed in 696 patients with a mean age of 61.1 years. Technical success was broken down into three categories: cannulation (insertion of a catheter or wire into the preferred bile or pancreas duct), stone removal, and drainage. Each physician completed pre-procedure and post-procedure forms that included patient information, physician intent, findings, grade of difficulty, and technical aspects of the procedure.
ERCP was performed because of known or suspected bile duct stones in over 50 percent of the procedures. A therapeutic intervention (e.g., stone removal, stent placement) was performed in 78 percent of the ERCPs. The overall complication rate following ERCP was five percent, with pancreatitis (post-ERCP pain due to temporary inflammation of the pancreas) being the most common complication at a rate of 3.2 percent. Hemorrhage (bleeding) occurred in less than one percent of procedures.
The ASGE/ACG Task Force has recommended competence levels for cannulation of the bile duct (90 percent), bile duct stone removal (85 percent), and bile duct drainage of a blocked duct (90 percent). This group of gastroenterologists performing ERCP in a community, non-academic setting met or exceeded these levels of success. Cannulation was successful in 94 percent, stone removal in 87 percent and drainage in 90 percent of the cases.
Researchers noted that these results may not be applicable to all community practices. The study center, Minnesota Gastroenterology PA, is a very large private practice composed of approximately 50 gastroenterologists allowing for a degree of specialization within the practice. The select group of physicians performing ERCP had a mean of 16.6 years of ERCP experience. Although this study did not find any relationship between years of experience and complication rates, several previous studies demonstrated a relationship. Further, the observation in previous studies that more complex cases tend to be handled at academic centers while "routine" cases are managed at community centers diminishes the ability to compare outcomes and complication rates between the two venues.
The study authors conclude that their results address issues that have not previously been well-studied and, when taken together with data from academic departments, provide a more complete picture of ERCP quality indices.