It's mid-morning at Beth Israel Deaconess Medical Center, and the patient is lying flat on her back in the operating room, sedated. Her belly gently swells and falls as she breathes.
Dr. Rabi Kundu begins an intestinal bypass, an operation sometimes used to treat obesity and cancer. But he does not cut into the smooth, pink skin in front of him. Instead, he passes a tube through the patient's lips and mouth, and down the esophagus to the stomach.
Over the next three hours, Kundu makes a tiny cut in the stomach wall, burrows through it and snips off a nearby, dime-sized loop of small intestine. He carefully sews the remaining intestine together with a network of spidery strings, all with tools he inserts down the tube.
At one point, he half-jokingly calls out, "history in the making," and indeed, he's in the midst of an extraordinary feat - even if the patient is only a pig.
If what Kundu is doing becomes a standard procedure in humans, it will significantly change the field of surgery.
Surgeons like to say that "to cut is to cure." But this type of operation, called "natural orifice translumenal endoscopic surgery" - NOTES for short - does not involve cutting the skin at all. That's the point of it. In NOTES, doctors access patients' insides through the mouth or other orifices, while looking through a camera at the end of the tube. They largely perform the procedures through a hole in the stomach.
Patients leave the operating room with no external scars whatsoever. Moreover, they may leave in considerably less pain and run less risk of infections.
"The holy grail is that it would be like getting a root canal - you go in [for surgery] and you can go to work the next day," says Dr. David Rattner, chief of general and gastrointestinal surgery at Massachusetts General Hospital. But, he adds, "whether that's achievable and realistic, nobody knows right now."
No one has yet had the temerity, or recklessness, to perform a NOTES procedure as complex as an intestinal bypass on a human. But already, doctors worldwide have performed more than 60 more straightforward NOTES operations.
In July, a team at Baystate Medical Center in Springfield treated a patient with a pancreatic lesion, accessing the "pseudocyst" through the patient's mouth. And in April, doctors in New York removed a woman's gallbladder through her vagina.
Several patients last year had their gallbladders taken out through their mouths. Albert Pagliuca, 44, of Gary, Ind., had his infected gallbladder removed that way in August at Northwestern Memorial Hospital in Chicago. Facing the prospect of a conventional operation instead, he says, "I got really nervous. I said to the doctor, isn't there a way to do this without cutting me open? And he said, 'Yes, well, there is a new procedure.'
"When he said I wouldn't have any stitches, that really made me think it was worth looking into. And if it's for science, why not?"
Pagliuca says he had "very little discomfort" after his NOTES procedure, and today he's "still happy to have done it."
Dozens more patients have had NOTES appendectomies and other simple operations abroad. Within the next few years, surgeons are likely to start attempting much more difficult procedures - intestinal bypasses like Kundu's, pancreatic resections, even weight-loss surgery.
Doctors at Beth Israel Deaconess, Mass. General, and Brigham and Women's Hospital in Boston, as well as at other top hospitals such as Johns Hopkins in Baltimore, are pioneering these operations in pigs and have begun to publish promising results in medical journals.
"I'm certain [NOTES is] going to move into humans," says Dr. Ram Chuttani, chief of interventional gastroenterology at Beth Israel Deaconess, "and it's going to happen relatively fast."
That may not be an entirely good thing. NOTES operations are more difficult than their conventional counterparts and physicians will need specialized training. When minimally invasive surgery took off in the early '80s, demand quickly outstripped the supply of doctors qualified to perform it. Patients were enticed by the prospect of less scarring, and they unwittingly risked their lives by going to surgeons who didn't have the proper training. Errors and malpractice suits predictably followed. Some patients died.
Doctors now worry that they may end up replaying the same scenario with NOTES - that it will become too popular, too fast, and that patients will ignore real medical risks in hopes of getting better cosmetic outcomes. "For doctors, the amount of additional risk you'd be willing to accept in order to have a scarless procedure is very small," says Dr. Field Willingham, a gastroenterologist at Mass. General. "But from the patient's perspective, it may be dramatically different."
According to a small survey presented at the Digestive Disease Week conference last year, patients would be willing to accept a 21 percent higher risk of complications if they were promised the prospect of going scar-free. That kind of enthusiasm is dangerous - for many operations, it could result in an unacceptably high complication rate. "There need to be brakes put on this by the medical community," says Chuttani. "Moving too quickly can harm both the patient and the field that's trying to progress."
Rattner, the Mass. General surgeon, is one of the doctors trying to put on the brakes. He has helped set rules for how trials in humans should proceed. If trials fail to meet the rules, their data may be viewed as suspect. The world's first human transgastric appendectomy, for instance, was apparently a success. Doctors in India reported that the patient did well. But the New England Journal of Medicine refused to publish the results because the surgery wasn't conducted under the established professional guidelines.
Animal trials, too, are starting to undergo more intense scrutiny as the possibility of moving into humans looms nearer. "One of the things that's really lacking right now in NOTES is rigorous research," says Willingham. "Most studies have been on two or three or 12 pigs, and most procedures that have been attempted have been very safe. . . . You would expect a low complication rate from those kinds of surgeries. They're low-hanging fruit."
Willingham recently finished the first large trial of a complex NOTES procedure in animals; he removed a part of the pancreas, via the mouth, in 28 pigs, some using NOTES and some using minimally invasive laparoscopy techniques. He plans to present his data at a conference this year, but says the incisionless approach turned out to be no riskier than its more traditional laparoscopic counterpart. One pig died after NOTES, and another died after laparoscopic surgery, but the other 26 did fine.
Even if animal trials continue to be promising, says Chuttani, NOTES will still face another obstacle before it's ready for human trials: Doctors don't yet have the tools they need to do it well. The endoscopes used in experiments such as Kundu's weren't designed to perform intricate operations deep in the abdominal cavity. Some are too big and clunky, and others are not flexible enough to reach all the organs easily.
In part, the animal trials are designed to give the medical-device industry ideas for new tools that could do a better job. The industry funds many of the trials and sends representatives to work alongside surgeons. Kundu, for instance, was assisted last month by NDO Surgical's Amos Cruz, who helped develop a promising new device, the "full-thickness plicator" - a sort of sewing machine that Cruz describes as looking "a bit like Jaws."
During Kundu and Cruz's operation, the plicator does its job well. But another device, designed to sew together tissue with wiry clips called "T-tags," doesn't perform nearly as smoothly. The first T-tag falls out of the intestinal tissue, and it takes almost an hour just to put in three of them.
Kundu eventually wraps up the procedure and pulls his tools out of the pig's mouth.
It will be a few days before this pig can eat normally, but when she goes back to her pen, her belly will still be smooth and scarless.
