--- More Doctors Get Inside View Of the Body With Video Pill; Close-Ups of a Tumor Site

By Marilyn Chase 15 August 2002

The Wall Street Journal

(Copyright (c) 2002, Dow Jones & Company, Inc.)
KRISTEN PARSKE WAS TIRED of not knowing what was wrong with her. The 33-year-old homemaker was dangerously anemic from internal bleeding and had undergone a colonoscopy, barium X-rays and six other uncomfortable scopes and scans, but doctors hadn't pinpointed the source.
Ms. Parske, in Sacramento, Calif., could have had exploratory surgery -- a big operation with a six-week recovery. But she had a new option: swallowing a miniature camera in a pill. With one- and two-year-old daughters to care for, she went for the video pill.
Every year a million Americans get procedures done to examine the small intestine. Often, it takes test after test or even surgery to figure out what is wrong. The problems that can strike include ulcers, tumors, leaky vessels and inflammatory conditions like Crohn's disease and irritable bowel syndrome. But the upper intestine is hard to see with conventional imaging tools. "The 22 feet between the stomach and colon has been a black box," says Gavriel Meron, chief executive of Given Imaging Inc., the Yoqneam, Israel, company that makes the technology.
The tiny disposable camera in a plastic shell, known as capsule endoscopy, is an easy way to explore that internal terrain. Several thousand people have tried it in the U.S. so far, and it is increasingly available in hospitals around the country.
The technology, invented by a former missile designer, was cleared by the Food and Drug Administration in August 2001. In the U.S., 268 hospitals, clinics and medical practices have installed the system, which includes a workstation and software along with the capsule. The procedure, which costs as much as $1,500, is covered by insurers in 24 states, 17 of those with Medicare coverage, plus Washington, D.C., Puerto Rico and the U.S. Virgin Islands.
Because it is new, the video pill is mostly used after conventional tests have failed. Still, says Robynne Chutkan of Georgetown University Hospital in Washington, D.C., it already has carved out a key role in solving the mystery of gastrointestinal bleeding whose source is unknown.
Capsule endoscopy is "an amazing technology," says Ms. Parske's surgeon, Gregg Jossart. He sees a number of patients like Ms. Parske for whom "it will mean quicker diagnosis and cure."
Ms. Parske swallowed the smooth plastic capsule, which is like an oversize vitamin, and donned a thick Velcro belt loaded with a battery pack and a Walkman-size recording device. Electronic leads were attached to her torso. Over the next eight hours, she was free to stroll, eat or drink as the device meandered through her body, taking 60,000 flash pictures -- two per second -- and transmitting the pictures to the recording device. The single-use capsule passed out painlessly after 24 hours.
Then she returned the gear she had worn to her hospital, California Pacific Medical Center in San Francisco, where gastroenterologist Kenneth Binmoeller and nurse Martie Mattson loaded the data recorder onto a workstation.
On the screen, views of her body's interior unfolded like scenes from the 1966 sci-fi film "Fantastic Voyage," where doctors explore the body in a tiny submarine. Her intestine, a pulsing white-walled tunnel, was marbled with vessels resembling the canals on Mars.
"There," said Ms. Mattson while reviewing the video, freezing a frame. Two hours, 33 minutes and 16 seconds into the capsule's descent, the screen displayed a shiny red crater -- an ulcer eroding the inner intestinal wall. The ulcer, the source of Ms. Parske's anemia, was caused by a stromal cell tumor, a golf-ball-size growth of muscle cells, on the outer wall of the intestine. While benign, such tumors bleed, and later can turn malignant.
Dr. Jossart used data from the video pill to target the bleeding site. On June 3, he performed laparoscopic surgery to remove the tumor. The minimally invasive operation involved three small cuts as wide as her pinkie. Ms. Parske went home in four days. To be safe, doctors also prescribed a round of preventive chemotherapy to prevent any stray cells from becoming cancerous later on.
"My prognosis is good. I feel fine, and I have more energy than I've had in a long time," she says. "Capsule endoscopy offered great peace of mind because [the doctors] could actually see that something was wrong."
Dr. Binmoeller, who directs endoscopy services at the hospital, says Ms. Parske was an ideal candidate for the procedure. Diagnosing disease of the small bowel with older detection methods is "like finding a needle in a haystack," he says. "She had a mass and it was missed." But with the capsule, "the surgeon [could] target and treat" it.
But the video pill isn't designed for everybody. Patients with swallowing disorders, intestinal narrowing, or pacemakers aren't candidates. Nor is it a substitute, alas, for uncomfortable colonoscopy procedures, as the capsule doesn't take good pictures of the wider space of the colon. Also, the capsule procedure is purely diagnostic; doctors can't do a biopsy or cauterize bleeding on the spot -- as they can with an endoscopic probe inserted into the mouth.
Patients considering the procedure should discuss all diagnostic options with their doctor. Dr. Binmoeller says that before trying the capsule, patients should have a conventional endoscopy to check for problems in the esophagus and stomach, as well as a colonoscopy.
The equipment doesn't always perform perfectly. The camera, which captures a 140-degree angle, may fail to flash, leaving gaps in the video. Doctors occasionally must repeat the process with a new capsule. It may get stuck in a coil of intestine. In rare instances, doctors must operate or insert an endoscope to retrieve a stranded capsule. Such glitches occur in less than 1% of the thousands of patients who have used it, the company says.
Still, the video pill's use is expected to grow. Moshe Rubin and colleagues at Columbia Presbyterian Medical Center in New York plan to use the camera to study celiac sprue, a wheat allergy that triggers inflammation, digestive troubles and increased risk of cancer in the upper intestine. In the future, Given Imaging hopes to push the anatomical frontiers of the product line so edible cameras can film the whole digestive tract from esophagus to colon.
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Where to Get the Camera You Can Swallow

Here are the heaviest users of the technology. People seeking a hospital in their area can try the company Web site, www.givenimaging.com.

Baylor University Medical Center
Dallas 214-820-8895

California Pacific Medical Center
San Francisco 415-600-1151

Cedars-Sinai Medical Center
Los Angeles 310-423-6082

Georgetown University Medical Center
Washington, D.C. 202-784-1667

Indiana University Medical Center
Indianapolis 317-278-8137

Mayo Clinic
Rochester, Minn. 507-284-2141

Mt. Sinai Hospital
New York 212-369-6600

St. Elizabeth's Hospital
Boston 617-789-2423

Thomas Jefferson Univ. Hospital
Philadelphia 215-955-8900

U.C.L.A. Medical Center
Los Angeles 310-825-6676
Source: Given Imaging