Elsevier

Gastrointestinal Endoscopy

Volume 74, Issue 3, September 2011, Pages 496-503.e3
Gastrointestinal Endoscopy

Original article
Clinical endoscopy
A double-masked, randomized, placebo-controlled trial of temporary endoscopic mucosal gastric electrical stimulation for gastroparesis

https://doi.org/10.1016/j.gie.2011.05.022Get rights and content

Background

Endoscopically placed, temporary gastric electrical stimulation (tGES) may relieve symptoms of gastroparesis (Gp) and predict permanent gastric electrical stimulation (GES) outcomes.

Objective

To measure effects of 72 hours of temporary GES on Gp symptoms.

Design, Setting, and Patients

From 2005 to 2006, we conducted a hospital-based, randomized, placebo-controlled, crossover trial of two consecutive, 4-day sessions (session 1 and session 2), enrolling 58 patients (11 males, 47 females; mean age 46 years) with GP symptom histories of three etiologies (idiopathic, 38; diabetes mellitus, 13; postsurgical, 7).

Intervention

72 continuous hours temporary GES was provided for group A during session 1, and for group B during session 2.

Main Outcome Measurements

Symptoms measured daily; gastric emptying, electrogastrography, and quality of life measured at baseline and session close.

Results

In session 1, vomiting decreased in both groups, but was greater with stimulation, resulting in a day 3 difference of −1.02 (95% CI, −1.62 to −0.42; P < .001). Scores did not return to baseline during washout; on day 4, the difference persisted at −1.08 (95% CI, −1.81 to −0.35; P = .005). In session 2, vomiting slightly decreased with stimulation and slightly increased without it; at day 8, the nonactivated group had nonsignificantly greater vomiting, 0.12 (−0.68 to 0.92; P = .762). An overall treatment effect of a slight, nonsignificant daily decrease in average vomiting scores, −0.12 (−0.26 to 0.03; P = .116), was observed by pooling stimulation effects across sessions.

Limitations

Missing data; potential physiological imbalances between groups.

Conclusions

Although overall treatment effects were not significant, differences in favor of stimulation were suggested. Barriers to observing treatment effects included a decrease in vomiting for both groups during session 1, insufficient washout, and the absence of baseline vomiting for some patients. Future studies should better define inclusion criteria, use longer washout periods, randomize by etiology and baseline physiological findings, and pursue alternative designs. (Clinical trial registration number: 00432835.)

Section snippets

Methods

The Institutional Review Board at the University of Mississippi Medical Center approved all study protocols. An investigative device exemption was received from the Food and Drug Administration, and the study, conducted from July 2005 through October 2006, with long-term follow-up through November 2007, was registered as Clinical Trial 00432835.

Results

Table 1 provides a summary of patient baseline symptoms, demographics, and physiology for all study participants. Most study participants were female and white, had idiopathic Gp, and ranged in age from 23 to 77 years. Randomization produced a reasonably good balance among baseline inclusion characteristics. Nevertheless, the baseline vomiting score was 1.82 for group A and 2.68 for group B (differential = −0.86; 95% CI, −1.70 to −0.03; P = .043), implying some difference in the primary outcome

Discussion

The primary aim of this masked, crossover study was to measure the reduction of patient-reported GI symptoms during 72-hours of endoscopically implanted, tGES. Vomiting decreased for both stimulated and nonstimulated groups in session 1, with a larger decrease for the stimulated group (90%) than for the nonstimulated group (55%). In session 2, changes in symptoms were more moderate for both groups, leading to a nonsignificant overall treatment effect. Treatment effects appeared somewhat

Conclusion

This double-masked, randomized, crossover study showed that endoscopically placed, tGES may reduce symptoms such as vomiting and nausea. tGES may help indicate whether a patient is likely to benefit from permanent stimulation, sparing both cost and invasive surgery in patients in whom tGES does not provide relief. Unexpected difficulties that arose during the study impede our ability to make conclusive therapeutic statements; however, we did note important differences between stimulation groups

Acknowledgments

The authors thank Edy Sofer, MD, and Warren Starkebaum, PhD, for their suggestions on trial design. We also thank Greg O'Grady, MD, for his review of the manuscript. Finally, we thank the staff of the GI Division, GI Laboratory, and Department of Nuclear Medicine at the University of Mississippi Medical Center for their help with this study, and Jo Anne Fordham for her assistance with manuscript production.

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DISCLOSURE: The following author disclosed a financial relationship relevant to this publication: Dr. Abell: a licensee, consultant, and investigator for Medtronic, Inc. The other authors disclosed no financial relationships relevant to this publication. Supported in part by Medtronic, Inc. The University of Mississippi has filed an Intellectual Property claim regarding aspects of the technology used in this study.

If you would like to chat with an author of this article, you may contact Dr. Abell at [email protected].

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