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Screening endoscopy for balloons

Is screening endoscopy required for intragastric balloons?

The research team correlated endoscopic findings from balloon placement to the patient history and to endoscopic findings upon balloon removal and then evaluated what aspects of the patient history were most critical to assess

Intragastric balloons may safely be placed without endoscopy using fluoroscopic guidance and a careful screening history prior to placement, according to research by Dr Elisabeth M H Mathus-Vliegen and colleagues, from the Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands. The study, which evaluated the usefulness of screening endoscopy and to assess patients who had balloons placed without endoscopy, also reports that prior screening does not predict complications during balloon therapy.

For their study, the research team correlated endoscopic findings from balloon placement to the patient history and to endoscopic findings upon balloon removal and then evaluated what aspects of the patient history were most critical to assess. Using these results, they studied the outcome of patients who had an unremarkable history in whom the balloon was placed only with fluoroscopy.

The paper, ‘Is Endoscopy Really Necessary for Placing Intragastric Balloons?’, published in Obesity Surgery, evaluated patients who had their balloons inserted after a screening endoscopy or under direct endoscopic visualisation (cohort 1). Then, they followed patients who had balloons inserted under fluoroscopy without endoscopy after a detailed medical history (cohort 2).

All patients referred for intragastric balloon therapy were screened using a detailed medical history focusing on upper gastrointestinal symptoms such as heartburn, belching, nausea, vomiting, epigastric pain/dyspepsia, as well as the patients diet and posture, a history of peptic ulcer disease, the presence of a hiatal hernia, medication use.

In order to guarantee a consistent reporting of the history, only patients who participated in previous clinical trials conducted by the author were included.

In cohort 1, two different balloons were (Wilson-Cook balloons (Wilson-Cook Medical,) and the Ballobes balloon (DOT ApS) were inserted after a screening endoscopy. The balloons were placed immediately after removal of the endoscope. For the third balloon (Orbera balloon), the endoscopy was performed and then the balloon was inserted and filled under direct endoscopic visualisation.

In cohort 2, no endoscopy was performed but the diaphragm was visualised under fluoroscopy and the Orbera balloon positioned 10 cm below the diaphragm.

Outcomes

A total of 253 patients were part of cohort 1 and 50 were part of cohort 2, with no differences between cohort 1 and cohort 2 in age, body weight and BMI.

In cohort 1, a reliable medical history was present in 250 and full endoscopic reports were available in 243 patients. After the screening endoscopy, 57 patients elected for bariatric surgery and thus did not participate in balloon therapy. Of note, these patients underwent upper abdominal X-rays with contrast and thus allowed for comparison to endoscopic findings, specifically with regard to presence of hiatal hernia.

One hundred fifteen patients had a Wilson-Cook balloon and 28 had a Ballobes balloon with confirmation of positioning by subsequent abdominal X-ray. In 52 patients, the Orbera balloon was inserted under direct endoscopic visualisation.

Eighty-five (34%) patients had diet-related heartburn with no position dependence and only 16 (6.4%) needed antacids, H2 blockers or PPIs; 27 (10.8%) had epigastric pain or dyspepsia and 13 (5.2%) had a known hiatal hernia. On screening endoscopy, the only major findings were grade D oesophagitis combined with a large hiatal hernia in one patient and a peptic ulcer in another. Both patients complained of severe symptoms on history.

Of the 151 patients with follow-up endoscopy after balloon removal, four (2.6%) patients did not tolerate the balloon and upon endoscopy, no abnormalities were found, and two (1.3%) patients reacted favourably to adjustment in balloon volume. Another four (2.6%) did not tolerate the balloon and were found to have either grade D (n=2), grade C (n=1) or grade B (n=1) oesophagitis which rapidly healed after removal of the balloon. Eleven (7.3%) patients had ulcers: seven were asymptomatic, two had symptoms of balloon intolerance not necessitating balloon removal and two presented with bleeding ulcers. Neither the patient history nor the findings on screening or placement endoscopy correlated to these adverse events.

There were three instances of balloon removal itself resulting in lacerations at the gastro-oesophageal junction caused by vomiting, one of which was a Mallory-Weiss tear.

In cohort 2, the same detailed history was carried out for each patient. Special attention was given to the details on history that came forward from cohort 1. No patient reported any gastrointestinal symptoms. The Orbera balloon was then placed without endoscopy, under fluoroscopic guidance.

Following the removal of the Orbera balloon, there were “minimal findings” on endoscopy. Thirty-nine (90.7%) patients had no findings on endoscopy and three patients did not tolerate the balloon.

“Given our experience and the available literature, other than a careful history, the only intervention that appears to protect patients prior to balloon therapy is to begin acid suppression therapy…Not only is the yield of endoscopy as a screening procedure for balloon therapy very low, it is expensive and not without risk,” the authors note.

They also stated that serious adverse events can occur during the endoscopic removal of intragastric balloons, such as oesophageal perforation, bleeding and aspiration pneumonitis.

“Our experience demonstrates that intragastric balloons may safely be placed without endoscopy using fluoroscopic guidance and a careful screening history prior to placement,” the researchers conclude. “Moreover, endoscopy prior to balloon placement does not predict complications during balloon therapy, and endoscopy is not without risk, particularly during intragastric balloon removal.”

To access this paper, please click here

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