Most recent update: Tuesday, July 16, 2019 - 19:15

Bariatric News - Cookies & privacy policy

You are here

Endoscopic bariatric therapies

Endoscopic bariatric therapies can be effective

The researchers undertook a comprehensive literature review and 82 papers for Orbera IGBs and 11 papers for EndoBarrier DJBS, which were included in the meta-analyses

A meta-analysis from the American Society for Gastrointestinal Endoscopy (ASGE) has concluded that endoscopic bariatric therapies (EBTs) can be effective options and are most beneficial when used as part of a comprehensive, multidisciplinary treatment programme. The review and analysis, ‘ASGE Bariatric Endoscopy Task Force systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting endoscopic bariatric therapies.’, published in Gastrointestinal Endoscopy and written by members of the ASGE Bariatric Endoscopy Task Force and the ASGE Technology Committee, analysed all of the currently available literature for endoscopic bariatric therapies and identified devices that had been extensively studied.

Christopher C Thompson

"Endoscopic bariatric therapies offer a viable, safe alternative for patients who have been unsuccessful at weight loss with diet and exercise,” said Christopher C Thompson, chair of the ASGE Bariatric Endoscopy Task Force. They may also be appropriate for patients who are not suitable for, or are unwilling to undergo, a more invasive surgical procedure.”

The ASGE systematic review and meta-analysis assessed EBTs using diagnostic/therapeutic thresholds established in 2012 as part of its Preservation and Incorporation of Valuable endoscopic Innovations (PIVI) initiative. The PIVI programme was initiated to identify important clinical questions related to endoscopy and to establish reasoned diagnostic and/or therapeutic thresholds for endoscopic technologies designed to resolve these questions.

After conducting a comprehensive search of several English-language databases, they performed direct meta-analyses by using random-effects models to assess whether the Orbera intragastric balloon (IGB) (Apollo Endosurgery) and the EndoBarrier duodenal-jejunal bypass sleeve (DJBS, GI Dynamics) have met the PIVI thresholds.

The paper states that EBT should be performed in the context of a comprehensive, multidisciplinary treatment programme including nutritional support, nursing care, behavioural medicine and other components of obesity management. Both didactic and hands-on endoscopic training and skill acquisition with EBT techniques, technologies and clinical management of obese patients will be needed before performing EBT procedures.

The researchers undertook a comprehensive literature  review and 82 papers for Orbera IGBs and 11 papers for EndoBarrier DJBS, which were included in the meta-analyses (Figure 1, Figure 2).

Figure 1: Flow diagram depicting search findings and study selection for inclusion in the intragastric balloon meta-analyses. CCRT, Cochrane Central Register of Controlled Trials; CDSR, Cochrane Database of Systematic Reviews; %EWL, percentage of excess weight loss; %TBWL, percentage of total body weight loss

Figure 2: Flow diagram depicting search findings and study selection for inclusion in the EndoBarrier meta-analyses. CCRT, Cochrane Central Register of Controlled Trials; CDSR, Cochrane Database of Systematic Reviews; %EWL, percentage of excess weight loss; HgA1c, glycosylated hemoglobin; RCTs, randomized, controlled trials

Orbera IGB

Based on a meta-analysis of 17 studies including 1,638 patients, the %EWL with the Orbera IGB at 12 months was 25.44 (95% CI, 21.47-29.4). This finding was associated with a high degree of heterogeneity (I2=97.4%). There was no evidence of publication bias based on a visual inspection of the funnel plot. Three RCTs compared %EWL in patients who received the Orbera IGB (n=131) with a control group (n=95). The mean difference in %EWL in patients who received the Orbera IGB over controls was 26.9% (95% CI, 15.6–38.2; p≤0.001). This finding was associated with a high degree of heterogeneity (I2 = 87.6%). There was no evidence of publication bias based on a visual inspection of the funnel plot.

EndoBarrier DJBS

Three studies enrolling 105 patients indicated that the EndoBarrier DJBS may exceed the PIVI threshold of 25% EWL at 12 months by achieving a %EWL of 35.3% (95% CI, 24.6-46.1) at 12 months. Four RCTs compared 12 to 24 weeks of treatment with the EndoBarrier DJBS (90 subjects) with a sham or control arm (84 subjects). The mean %EWL difference compared with a control group was significant at 9.4% (95% CI, 8.26–10.65).

The pooled %EWL of the EndoBarrier DJBS over control did not meet the 15% PIVI threshold; however, the duration of these studies (12-24 weeks) was 25% to 50% of the current duration of treatment with the EndoBarrier DJBS (12 months). Both of the above findings were associated with a high degree of heterogeneity, but there was no evidence of publication bias on visual inspection of the funnel plot.

"EBTs should complement, rather than compete with, current obesity therapy options and should be used as adjunctive therapy as outlined in a previous ASGE publication.”

The EndoBarrier DJBS demonstrated an impact on diabetic control after implantation, with improvements in HgA1c from −0.7 (95% CI, −1.76 to 0.2; p=0.16) at 12 weeks to −1.7 (95% CI, −2.5 to -0.86; p<0.001) at 24 weeks, and −1.5 (95% CI, −2.2 to −0.78; p<0.001) after 52 weeks implantation. This improvement in HgA1c is statistically significant compared with a sham or control diabetic group, where the EndoBarrier DJBS resulted in an additional −1% (95% CI, −1.67 to −0.4; p=0.001) improvement in HgA1c compared with that seen in controls.

Sufficient data (>5 studies reporting %TBWL at 6 months) were available to evaluate the effectiveness of the Orbera IGB as bridge (nonprimary) obesity therapy. The PIVI sets a threshold of 5% TBWL for nonprimary (bridge) EBTs. The pooled %TBWL after Orbera IGB implantation was 12.3% (95% CI, 7.91–16.73), 13.16% (95% CI, 12.37–13.95), and 11.27% (95% CI, 8.17–14.36) at 3, 6, and 12 months after implantation, respectively. For an EBT to be used as nonprimary (bridge) obesity therapy, it needs to perform sufficiently well in patients with a BMI>40. A subsequent meta-regression to assess the efficacy of the Orbera IGB in patients within a range of BMIs, demonstrated the association between the baseline BMI and the %TBWL achieved at six months after Orbera IGB implantation. This showed no statistically significant difference (p=0.09) in %TBWL over a wide range of BMIs, indicating that the Orbera IGB performs as well in higher BMI groups and thus might be effective as a non-primary (bridge) EBT.

Safety

The rates of adverse events after implantation of the Orbera IGB were pooled from a manual review of 68 studies and are summarised in Figure 3. Pain and nausea were frequent side effects after Orbera IGB implantation, occurring in 33.7% of subjects. The early removal rate for the Orbera IGB was approximately 7%. Serious side effects with the Orbera IGB were rare, with an incidence of migration and gastric perforation of 1.4% and 0.1%, respectively. Fifty percent (4/8) of gastric perforations with the Orbera IGB occurred in patients who had undergone previous gastric surgeries. Four deaths associated with the Orbera IGB are reported in the literature, and these were either related to gastric perforation or an aspiration event.

Figure 3: Pooled rates of adverse events observed with the Orbera intragastric balloon (IGB). SBO, small bowel obstruction

The published safety profile of the EndoBarrier DJBS appears favorable based on experience with 271 implantations detailed in the literature. The incidence of early removal and adverse events are detailed in Figure 4. Serious adverse events included migration (4.9%), GI bleeding (3.86%), sleeve obstruction (3.4%), liver abscess (0.126%), cholangitis (0.126%), acute cholecystitis (0.126%), and esophageal perforation (0.126%) secondary to trauma from an uncovered barb at withdrawal. The multi-centre ENDO pivotal trial was discontinued in July 2015 after reports of hepatic abscesses.

Figure 4: Pooled rates of adverse events observed with the EndoBarrier

“Considering the modest effects seen with medications or lifestyle intervention alone in patients with obesity, EBTs appear well suited to bridge the current management gap by offering an effective weight loss intervention with potentially lower risks, lower costs, and higher patient acceptability. These benefits of EBTs will need to be studied and documented as we move forward in the management of obesity…As stated earlier, these recommendations should not be taken to imply that these devices could be used on their own without appropriate screening, dietary, and lifestyle intervention support, nor should they be used without consideration of surgical therapy. These devices should be used in conjunction with other stakeholders taking care of patients with obesity, such as medical obesity specialists, behavioral therapy professionals, registered dietitians, and bariatric surgeons. EBTs should complement, rather than compete with, current obesity therapy options and should be used as adjunctive therapy as outlined in a previous ASGE publication.”

The ASGE said that it will continue to work with ASGE members and other medical societies involved in obesity therapy to promote and facilitate widespread adoption and implementation of safe and effective EBTs in clinical practice.

To access this paper, please click here

Want more stories like this? Subscribe to Bariatric News!

Bariatric News
Keep up to date! Get the latest news in your inbox. NOTE: Bariatric News WILL NOT pass on your details to 3rd parties. However, you may receive ‘marketing emails’ sent by us on behalf of 3rd parties.