GI Bleeding and the Endoclip

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Gastroenterologists and their staff have to be prepared for a myriad of events while they work, one of the most prominent being gastrointestinal (GI) bleeding. They also need to be aware of the best possible treatments to apply, such as endoclips, when bleeding does occur.

Bleeding can happen anywhere, any time and at any age, within the GI tract between the mouth and the anus. Healthcare providers must be prepared to deal with a number of potential reasons, which can cause a wide range of bleeding — from small and undetectable to massive and life-threatening.

To aid in diagnosis, GI bleeding is often divided into two subgroups based on where the bleeding occurs: upper GI bleeding and lower GI bleeding. The upper GI tract is located between the mouth and the outflow tract of the stomach, and the lower GI tract is located from the outflow tract of the stomach to the anus.

Finding GI bleeding is extremely important as it may be a symptom of a serious disease or condition. For example: “Prolonged microscopic bleeding can lead to massive loss of iron, causing anemia,” according to the U.S. National Institutes of Health. “Acute, massive bleeding can lead to hypovolemia, shock and even death.”

Symptoms and Causes

Detecting GI bleeding can be difficult, as there can be many sources. The American College of Gastroenterology (ACG) says a person can have GI bleeding without having any pain. ACG further breaks down the symptoms of bleeding based on where they occur in the GI tract. Symptoms of upper GI bleeding include the vomiting of bright red blood, vomiting dark clots or coffee-ground-like material or passing black, tar-like stool. Lower GI bleeding symptoms, according to ACG, include passing pure blood or blood mixed in stool or bright red or maroon-colored blood in the stool.

According to the American Society of Gastrointestinal Endoscopy (ASGE), the following are common causes for upper GI bleeding.

  • Peptic ulcer disease
  • Gastroduodenal erosions
  • Esophagitis
  • Varices
  • Mallory-Weiss tear
  • Vascular malformations

Conversely, the ASGE lists the following as common causes for lower GI bleeding.

  • Diverticulosis
  • Angiodysplasia
  • Hemorrhoids
  • Colonic neoplasia malignancy
  • Intussusception
  • Varices

Ulcers as a Cause of GI Bleeding

The stereotype of an overworked American clutching his stomach and complaining of an ulcer rings true for many people. A nagging, burning pain in the abdomen, lasting a few minutes to hours, is the most common symptom of an ulcer. Unfortunately, ulcers can be a common culprit for GI bleeding.

Ulcers occur when digestive juices and stomach acid destroy the lining of the stomach or duodenum. They can cause bleeding in the stomach and the duodenum. If they aren’t treated, the stomach acid and digestive juices can tear through the intestinal lining, causing perforation, which often requires surgery. An untreated ulcer can also swell and scar to the point of blocking food from passing from the stomach, resulting in vomiting and weight loss.

Ulcers can be diagnosed through endoscopy or the X-ray test known as the upper GI series. Cigarette smoking has been shown to slow down the healing process and has been linked to recurrence, so doctors recommend that patients who smoke stop smoking. In addition, NSAIDs should not be taken, unless a doctor says otherwise.

Contrary to popular belief, ulcers are not stress-induced, and patients with ulcers are often infected with the bacteria Helicobacter pylori, which can be treated with antibiotics. Ulcers can also be caused by regular use of the class of pain medications known as non-steroidal anti-inflammatory drugs (NSAIDs), which include aspirin and ibuprofen.

Ibuprofen Risk

Ibuprofen is generally considered one of the safest painkillers on the market, but a 2005 clinical study showed that high doses of the treatment could cause GI bleeding, even in healthy adults.

People who take high doses of ibuprofen on a regular basis are three times more likely to experience GI bleeding than those who do not take painkillers, according to results published November 2005 in the journal Clinical Gastroenterology and Hepatology.

“Unfortunately, people dealing with chronic pain, such as arthritis, often increase the recommended dose of their painkillers, and they should be aware that the effects on the GI tract can be serious,” says Richard H. Hunt, MD, senior study author from the McMaster University Health Science Centre. “Of all the NSAIDs available over-the-counter, ibuprofen was thought to have the least harmful effects on the GI tract. However, our study shows that healthy young people and older people are at great risk of internal bleeding and should speak with their doctor to determine the risks of taking large amounts of ibuprofen.”

Researchers from the McMaster University Health Science Centre in Ontario, Canada, conducted a post-hoc analysis of two separate randomized studies that included 68 healthy volunteers who were given either four weeks of an ibuprofen regimen (800 mg three times daily for 28 days) — a dosage amount twice that of the recommended 1,200 mg per day — or a placebo. Prior to starting the regimen, patients were evaluated for a one-week control period to demonstrate that they were not bleeding.

Of the healthy subjects included in the study, those taking ibuprofen for 28 days experienced blood loss that was 3.64-fold greater than the placebo group. On average, those taking ibuprofen experienced blood loss as low as 40 mL (approx. 1/5 cup) and as high as 299 mL (approx. 1 cup). Bleeding was found to begin as early as three days after the start of the treatment and generally lasted the entire duration of the study in most subjects. According to study authors and previous studies, although the ibuprofen dose was higher than the recommended over-the-counter amount, blood loss, anemia and other adverse events can be observed at any dose of ibuprofen.

“The potential for serious GI complications should always be considered when ibuprofen is recommended for at-home use,” says Hunt. “Elderly people and those with debilitating conditions such as arthritis should be especially cautious about the medications they are taking together and the adverse effects of those interactions. Serious bleeding can always occur even with over-the-counter drugs that are considered safe.”

NSAIDs have also been shown to cause GI bleeding in children. An April 2007 study in the Journal of Pediatric Gastroenterology and Nutrition followed four children between 16 and 36 months old who took NSAIDs. The researchers found the children developed hematemesis after taking ibuprofen to control fevers. “Although the number of patients in our report is small, these findings suggest initially treating fever with acetaminophen instead of NSAIDs,” the researchers write. “This is based on our reported experience, as well as that of others who reported hospitalizations because of gastrointestinal bleeding in patients receiving ibuprofen only. Because of the relative young age of our described patients, patients younger than 36 months may be at an increased risk for the development of gastrointestinal bleeding after the use of NSAIDs.”

New Treatments for GI Bleeding

Standard endoscopic therapies, radiologically guided interventions and surgery are the conventional treatments used to stop gastrointestinal bleeding, but a recent Mayo Clinic study found that endoscopic ultrasound-guided therapy appears to be a safe and effective treatment for patients with severe GI bleeding for whom conventional therapies have failed.

“Despite advances in conventional therapies, recurrent bleeding is common in many patients,” says Michael Levy, MD, an author of this study and a gastroenterologist at Mayo Clinic. “At times, there are no options for patients with severe and refractory bleeding and, unfortunately in this setting, the morbidity and mortality are high.”

Levy and a team of Mayo Clinic physicians set out to identify more effective therapies to control bleeding and manage recurrent bleeding if standard therapies do not work. The team reviewed the results of five patients with severe gastrointestinal bleeding who received endoscopic ultrasound-guided therapy. The study was published in the February issue of American Journal of Gastroenterology.

“Endoscopic ultrasound imaging often provides more detailed information about the appearance, size, and precise location of bleeding than other endoscopic or radiologic imaging modalities,” Levy says. “Equally important, endoscopic ultrasound provides specific details about the anatomy of the blood vessels surrounding the bleeding so therapy can be precisely delivered to the most effective location.”

Each patient in the study had experienced at least two episodes of severe bleeding and at least two attempts at conventional therapy to control the bleeding had not worked. Using endoscopic ultrasound guidance, the team was able to identify and characterize the location of each patient’s bleeding. With the specific site of bleeding in view, various agents such as 99 percent alcohol or medical glue were injected directly into the source to stop the bleeding. Following this therapy, none of the five patients experienced recurrent bleeding and no complications were reported.

The Use of Endoclips

Endoclips also are a common medical device used during endoscopy to treat GI bleeding. They help patients avoid the need for surgery and suturing. Like a clamp, an endoclip is device used to close two mucosal surfaces that cause bleeding. Endoclips can be placed through an endoscope to treat upper and lower GI bleeding. They can help prevent bleeding after a polypectomy and help with closing perforations in the GI tract.

“Initial indication is hemostasis, but it has since been applied elsewhere,” says Douglas Janowski, MD, from Tufts New England Medical Center. “I’ve used [the clip] from every circumstance, working my way through the GI tract from closure hemostasis of a Mallory-Weiss tear in the esophagus, to the clipping of a vessel of an ulcer in the stomach or duodenum, to clipping bleeding after a polypectomy.”

Once a lesion is identified on endoscopy to be treatable, an endoclip is inserted through the endoscope until the sheathed clip is visible on the image. The nurse assistant is given the deployment handle, and then the clip is unsheathed by retracting the handle. The assistant then positions the clip and “fires” it to treat the lesion.

Endoscopists traditionally achieve endoscopic hemostasis with a combination of injection therapy and electrocautery. However, electrocautery is often associated with risks and complications, such as recurrent bleeding and delayed ulcer healing. Alternatively, endoscopic hemostasis can be achieved with mechanical clips alone, or in combination with injection therapy.

Thermal therapy, i.e., burning the blood vessel to stop its bleeding, is one alternative to endoclips. Physicians can also inject epinephrine to constrict the blood vessel. Gastroenterologists have yet to truly determine which treatments are better, but many comparative studies argue that endoclips are less traumatic to the lining around the ulcer than thermal therapy.

A study led by Sri Komanduri, MD, of Rush University Medical Center in Chicago analyzed the use of Boston Scientific’s Resolution Clip as an alternative to electrocautery as the primary mechanism of hemostasis after epinephrine injection. Results showed that adequate endoscopic hemostasis was achieved with the use of Resolution Clip instead of electrocautery in combination with injection therapy in all patients. None of the cases in the study required electrocautery and none of the patients had clinical or laboratory evidence of rebleeding.

Boston Scientific’s clip is a pre-loaded, 11 mm-wide endoscopic mechanical clip for upper and lower GI bleeding. It is engineered to allow a physician to open and close the clip up to five times prior to deployment.

Clips may not only provide a lower rebleeding rate, but also may cause less tissue reaction. Janowski says the staying power and the ease of deployment are a few advantages of the Boston Scientific clip. “One of the things that’s nice about the Boston Scientific clip is the ability to open and close,” says Janowski. “That becomes useful in the circumstances when maybe you’re not happy with your positioning or there’s something that knocks you out of position. The open and closing is very nice.”

Using the Clips in Practice

Endoclip training is relatively straightforward and easy, says Janowski. “In some ways it’s similar to doing a biopsy forcep. Really, the greater training falls on the nurse or the medical assistant, whoever it is who is actually operating the clip while the physician is positioning it into place.”

Training can happen with a local medical device rep or with colleagues, says Janowski. You can apply it to a sponge to get the feel of how it works. “Then it just becomes the experience of using them,” he adds. “I have to say, my technique improved over my first 20 clips. One has to bear in mind that a clip will occasionally misfire. That’s okay. Put another one down. Sometimes it’ll be a one-shot deal. Sometimes it’ll be a four-, five- or six-shot deal. That’s just the way that it goes.”

One reason for redeployment could be that the tissue doesn’t hold the way the physician would like it to, according to Janowski. The size of the vessel could also affect the capability of the clip. But the more people use, the more they develop their own techniques. “The important thing is to apply your clips, evaluate them, make sure the bleeding has stopped and then call it a day,” says Janowski.

As for future design of endoclips, Janowski is actually working with Boston Scientific to make it even easier to use. He has trialed some prototypes the company has for future use. One area they are working on is to better position the clip when the torqueing of the scope can limit the clip’s positioning. He also says he believed there could be greater rotation on the clip. “That just makes the device all the more facile and agile,” he adds.

He says he would also like to see a family of clips become available. “For example, the barrel on the end of clips can be a little long. In most circumstance that’s good, but there are circumstances where perhaps you would be happier with a shorter barrel for positioning in a tight space. It would be nice to have a little bit of variability in regards to that.”

In the end, Janowski says the endoclip is a very useful tool that doctors and nurses need to become comfortable with, regardless of the brand. “They should realize how it expands the assets and armament as they go after hemostasis,” he adds. “It really adds to [the ability to] induce hemostasis on our patients.”

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