Panel Issues Recommendations Regarding Common Clinical GI Procedure

An independent, non-Federal panel convened by the National Institutes of Health (NIH) concluded today that in light of rapid advances in medical imaging technologies, Endoscopic Retrograde Cholangiopancreatography (ERCP) is evolving into a therapeutic, rather than diagnostic tool. The panel predicted that less invasive imaging techniques will soon eclipse ERCP's value as a tool for diagnosing pancreaticobiliary diseases, but the procedure continues to hold great utility in treatment of both benign and malignant diseases of the pancreas and biliary tract.

First used about 30 years ago, ERCP is currently used by physicians to diagnose and treat problems in the liver, gallbladder, bile ducts, and pancreas. ERCP requires conscious sedation, and combines the use of x-rays and an endoscope �� a long, flexible lighted tube �� which is inserted in a patient's mouth and guided through the esophagus, stomach, and small intestine. The procedure allows the physician to look inside these organs and to inject dye into the bile and pancreatic ducts, making them visible on an x-ray.

"As we move toward a higher-risk, therapeutic procedure, it is important that we conduct high-quality studies to determine the safety, efficacy, and effectiveness of ERCP as compared to other surgical and non-surgical interventions," said panel chair Dr. Sidney Cohen, M.D., Professor of Medicine and Director of Research Programs in the Division of Gastroenterology and Hepatology at Jefferson Medical College, Thomas Jefferson University in Philadelphia.

The panel found that the available evidence supports ERCP's merit in treating several conditions including symptomatic gallstone disease, common bile duct stones, recurrent pancreatitis, and pancreatic pseudocysts. In addition, ERCP with endoscopic sphincterotomy and stone removal is valuable for patients with jaundice due to stones in the common bile duct, dilated common bile duct, cholangitis, or acute pancreatitis. The panel also noted, however, that the role of ERCP is unclear in the evaluation or management of abdominal pain without specific anatomic or biochemical abnormalities referable to the common bile duct or pancreas.

Panelists concluded that ERCP remains the best means for diagnosing suspected ampullary cancers and for patients with pancreatic or biliary cancer who are not candidates for surgery. In these cases, ERCP confers the advantage of palliation of biliary obstruction.

Though enthusiastic about ERCP's therapeutic potential, the panel was careful to note substantial risks involved in the procedure as well. The panel stressed that appropriate training and expertise are necessary, especially for advanced ERCP, and that avoiding unnecessary ERCP is the best way to reduce complications such as post-procedure pancreatitis. Because the highest rate of complications may occur in the group of patients that least needs ERCP, physicians must be particularly cautious with regard to patient selection, and avoid ERCP when, for example, there is a low likelihood of stone or stricture, especially in women with recurrent pain, a normal bilirubin, and no other sign of biliary disease.

The panel emphasized a critical need to improve the quality of clinical investigation in pancreaticobiliary diseases in general, and specifically ERCP, and to that end recommended formation of a cooperative group to foster multicenter involvement in the design and conduct of large clinical trials. The panel advocated randomized, prospective trials to assess both benefits and risks of ERCP compared to other diagnostic and therapeutic interventions for biliary and pancreatic problems.

The 13-member panel included representation from gastroenterology, hepatology, clinical epidemiology, oncology, biostatistics, surgery, health services research, radiology, internal medicine, and the public. The panel issued its statement at the conclusion of a two-and-a-half-day NIH State-of-the-Science Conference on Endoscopic Retrograde Cholangiopancreatography (ERCP) for Diagnosis and Therapy. The conference brought together experts to present the latest research on the procedure. The panel also reviewed an extensive collection of literature related to ERCP, including a systematic review of the available evidence prepared by the Blue Cross Blue Shield Technology Evaluation Center, an Evidence-based Practice Center under the auspices of Agency for Healthcare Research and Quality (AHRQ).

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the NIH Office of Medical Applications of Research sponsored the conference. Co-sponsors included the National Cancer Institute and the U.S. Food and Drug Administration.

The panel's statement is an independent report and is not a policy statement of the NIH or the Federal Government. The NIH Consensus Development Program, of which this state-of-the-science conference was a part, was established in 1977 as a mechanism to judge in an unbiased, impartial manner controversial topics in medicine and public health. NIH has conducted 115 consensus development conferences, and 19 state-of-the-science (formerly "technology assessment") conferences, addressing a wide range of issues.

The full text of the panel's statement will be available in draft form following the conference at http://consensus.nih.gov. Statements from past conferences are available at the same Web site, or by calling 1-888-NIH-CONSENSUS (1-888-644-2667).

A summary of the evidence report prepared by the Blue Cross Blue Shield Technology Evaluation Center under contract with AHRQ is available online at http://www.ahrq.gov/clinic/epcsums/ercpsum.htm. Print copies are also available from the AHRQ Publications Clearinghouse, by calling 1-800-358-9295.

Note to TV Editors: The news conference at 1:00 p.m. on Wednesday, January 16, 2002 will be broadcast live via satellite on the following coordinates:

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Note to Radio Editors: An audio report of the conference results will be available after 4:00 p.m. January 16, 2002, from the NIH Radio News Service, by calling 1-800-MED-DIAL (1-800-633-3425).