Balloon Dilation of Spincter of Oddi

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Balloon Dilation of the Sphincter of Oddi Usually Should Be Avoided CME

News Author: Laurie Barclay, MD

CME Author: Désirée Lie, MD, MSEd

Complete author affiliations and disclosures, and other CME information, are

available at the end of this activity.

Release Date: November 11, 2004; Valid for credit through November 11, 2005

Credits Available

Physicians - up to 0.25 AMA PRA category 1 credit(s)

All other healthcare professionals completing continuing education credit

for this activity will be issued a certificate of participation.

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completing the educational activity.

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Nov. 11, 2004 - Balloon dilation of the sphincter of Oddi is associated with

an increased risk of pancreatitis and death, compared with sphincterotomy

for bile duct stone extraction, according to the results of a randomized,

multicenter study published in the November issue of Gastroenterology. The

investigators recommend avoiding this procedure.

" Endoscopic retrograde cholangiopancreatography (ERCP) with sphincterotomy

is the standard of care for removal of bile duct stones, " write A.

Disario, MD, from the University of Utah Health Sciences Center in Salt Lake

City, and colleagues. " Balloon dilation of the sphincter of Oddi has been

proposed to enlarge the orifice for stone extraction and avoid short-term

and long-term morbidity of sphincterotomy.... The potential advantage of

balloon dilation is that the biliary sphincter may regain some function and

reduce the risk of long-term complications. "

In a broad spectrum of clinical and academic practices, 117 patients were

randomized to dilation and 120 to sphincterotomy. Clinical characteristics

of the patients, technical aspects of the procedures, and experience of the

endoscopists were similar in both groups, except that dilation patients were

younger.

Success rate of the procedure was 97.4% for dilation and 92.5% for

sphincterotomy. Overall morbidity was 17.9% vs 3.3% (P < .001; difference,

14.6; 95% confidence interval [CI], 7 to 22.3), and severe morbidity was

6.8% vs 0% (P < .004; difference, 6.8; 95% CI, 2.3 to 11.4), respectively.

There were two deaths (1.7%) from pancreatitis in the dilation group and

none in the sphincterotomy group.

Complications included pancreatitis (15.4% vs 0.8%; P < .001; difference,

14.6; 95% CI, 7.8 to 21.3), cystic duct fistula (1.7% vs 0%), cholangitis

(0.9% vs 0.8%), perforation (0% vs 0.8%), and cholecystitis (0% vs 0.8%).

Because of the clear increase in morbidity with dilation, the study was

terminated at the first interim analysis. Compared with the sphincterotomy

group, the dilation group required significantly more invasive procedures,

longer hospital stays, and longer time off from normal activities.

" In a broad spectrum of patients and practices, endoscopic balloon dilation

compared with sphincterotomy for biliary stone extraction is associated with

increased short-term morbidity rates and death due to pancreatitis, " the

authors write. " Balloon dilation of the sphincter of Oddi for stone

extraction should be avoided in routine practice. "

The National Institutes of Health, the American Digestive Health Foundation

(American Society for Gastrointestinal Endoscopy), the American College of

Gastroenterology, the Glaxo Wellcome Institute for Digestive Health, and

Boston Scientific Endoscopy supported this study.

Gastroenterology. 2004;127:1291-1299

Learning Objectives for This Educational Activity

Upon completion of this activity, participants will be able to:

a.. Describe short- and long-term complications of ERCP with

sphincterotomy vs endoscopic balloon dilation of the sphincter of Oddi for

bile duct stones.

b.. Compare the short-term outcomes of the two procedures.

Clinical Context

Gallstones occur in 10% to 15% of adults, and bile duct stones occur in up

to 15% of those with symptomatic gallstones. Gallstones are the most common

and costly digestive tract disorder in the U.S. ERCP with sphincterotomy is

the standard of care for removing bile duct stones and is successful in more

than 90% with reported 5% to 10% short-term and 4% to 24% long-term

morbidity. The biliary portion of the sphincter of Oddi is incised using a

diathermic wire for stones larger than the sphincter orifice. Potential

short-term morbidity includes pancreatitis, cholangitis, cystic duct

fistula, and cholecystitis. Permanent ablation of the sphincter may lead to

biliary reflux, increased lithogenicity, infection, and inflammation.

Long-term morbidity includes choledocholithiasis, cholangitis, sphincter

stenosis, and pain.

Balloon dilation of the sphincter of Oddi to enlarge the orifice for stone

extraction has been proposed to avoid the long-term morbidity of

sphincterotomy. Only uncontrolled studies have demonstrated similar rates of

morbidity to sphincterotomy, according to the authors of this study. The

current study is a multicenter, randomized controlled prospective trial

representative of routine practice at clinical and academic centers to

compare early outcomes of the two procedures in patients with bile duct

stones.

Study Highlights

a.. Inclusion criteria were older than 18 years, known or suspected bile

duct stones, and cholecystectomy previously or planned within 30 days.

b.. Exclusion criteria were acute condition such as pancreatitis or septic

shock, coagulopathy, sphincter dysfunction, stone larger than 10 mm

diameter, bile duct larger than 15 mm, more than 5 stones, prior

sphincterotomy, strictures or fistulas, and other surgery.

c.. ERCP and sphincterotomy were performed to incise the entire

sphincteric mound. Balloon dilation was performed with wire-guided

hydrostatic balloon to 8 mm or the maximum size of the duct whichever was

greater. Stones were removed by basket or balloon catheters, and mechanical

lithotripsy was used when stones were too large. Stents were placed at the

discretion of endoscopists who attested to their experience in both

procedures. Total number of endoscopists performing the procedures was not

stated.

d.. The study was terminated after the first interim analysis at 237

instead of the projected 710 patients required due to significant endpoint

differences between the two procedures. Analysis was by intent-to-treat.

e.. 117 patients were randomized to ERCP with balloon dilation and 120 to

sphincterotomy.

f.. Complications up to 30 days were compiled by chart review, case report

forms, and patient interview by standardized script.

g.. Success was defined by complete stone extraction at initial procedure.

h.. Complications were graded as mild, moderate, and severe, requiring

hospitalization for 2 to 3, 4 to 10, and more than 10 days with or without

further invasive radiographic intervention, respectively. Pancreatitis was

defined as serum amylase double the upper limit of normal, and cholangitis

was defined as right upper-quadrant pain, fever higher than 38ºC, and

elevated liver enzymes.

i.. Primary endpoints were difference in 30-day overall morbidity.

Secondary endpoints were rates of severe morbidity, mortality, and other

clinical indicators.

j.. Overall median age was 49 years (range, 17 to 89 years), and patients

receiving balloon dilation were younger (47 vs 54 years) than those in the

sphincterotomy group. More than 70% were women, average duct size was 10 mm,

and stone size was 5 to 6 mm. 50% had received prior cholecystectomy less

than one month before.

k.. Overall mean duration of follow-up was 31 days (range, 0 to 900 days).

5.9% were lost to follow-up.

l.. Mean duration of surgery was 42 to 47 minutes. 27% of patients

undergoing sphincterotomy vs 10.5% of those undergoing balloon dilation had

self-limited endoscopically controlled bleeding.

m.. Success was 97.4% for the balloon and 92.5% for the sphincterotomy

group.

n.. Overall morbidity at 30 days was 17.9% vs 3.3% for sphincterotomy vs

balloon dilation (P < .001; difference, 14.6; 95% CI, 7.0 to 22.3).

o.. Severe morbidity, including two deaths from pancreatitis, was 6.8% for

balloon dilation vs 0 for sphincterotomy (P = .004; difference, 6.8; 95% CI,

2.3 to 11.4).

p.. Complications for balloon dilation vs sphincterotomy included

pancreatitis (15.4% vs 0.8%; P < .001), cholangitis (0.9% vs 0.8%),

perforation (0% vs 0.8%), and cholecystitis (0% vs 0.8%).

q.. Balloon dilation was the only significant factor associated with

severe morbidity.

r.. For the sphincterotomy vs balloon dilation groups, abdominal pain (not

requiring attention) was reported in 23.9% vs 17.5%, persistent biliary

tract problems requiring physician visit in 12.8% vs 11.7%, respectively,

and bloody stools in less than 5%.

s.. Biliary endoprostheses were placed in 7.5% in the sphincterotomy vs

3.4% in the dilation group, and stent was placed in one patient in the

balloon group.

Pearls for Practice

a.. Short-term morbidity of ERCP with sphincterotomy or balloon dilation

includes pancreatitis, cholangitis, cystic duct fistula, and cholecystitis.

Long-term morbidity of sphincterotomy includes choledocholithiasis,

cholangitis, sphincter stenosis, and pain.

b.. Balloon dilation of the sphincter of Oddi for extraction of bile duct

stones is associated with increased short-term total and severe morbidity

and mortality from pancreatitis compared with sphincterotomy and should be

avoided in routine practice.

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Target Audience

This article is intended for gastroenterologists, interventional

radiologists, general surgeons, primary care physicians, and other

specialists who care for patients with bile duct and symptomatic gallstones

requiring removal.