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CC BY 4.0 · Journal of Digestive Endoscopy 2025; 16(03): 117-125
DOI: 10.1055/s-0045-1809900
Original Article

Novel Nonsurgical Treatment Modality for Gastroduodenal Outlet Obstruction: A Randomized Controlled Trial

Authors

  • Manasvin Sareen

    1   Department of Gastroenterology, Sawai Man Singh Medical College and Hospital, Jaipur, Rajasthan, India

  • Gireesh Kumar Dhaked

    1   Department of Gastroenterology, Sawai Man Singh Medical College and Hospital, Jaipur, Rajasthan, India

  • Garima Sharma

    2   Department of Pathology, Sawai Man Singh Medical College and Hospital, Jaipur, Rajasthan, India

  • Prachis Ashdhir

    1   Department of Gastroenterology, Sawai Man Singh Medical College and Hospital, Jaipur, Rajasthan, India

  • Ashok Jhajharia

    1   Department of Gastroenterology, Sawai Man Singh Medical College and Hospital, Jaipur, Rajasthan, India

  • Sandeep Nijhawan

    3   Department of Gastroenterology, Mahatma Gandhi Hospital, Jaipur, Rajasthan, India

  • Vidyadhar S. Nitar

    1   Department of Gastroenterology, Sawai Man Singh Medical College and Hospital, Jaipur, Rajasthan, India

Funding None.
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Abstract

Objectives

Gastric outlet obstruction (GOO) includes obstruction in the antropyloric area or in the bulbar or post-bulbar duodenum. Endoscopic balloon dilatation therapy combined with proton-pump inhibitors (PPIs) has been the standard of care. This study evaluates the efficacy of addition of misoprostol along with standard treatment versus standard treatment only in the treatment of GOO.

Materials and Methods

In this prospective, single-center, randomized controlled trial, consecutive patients of benign GOO were randomized into misoprostol + standard treatment (intervention arm) versus standard treatment only (control arm) into 1:1 ratio.

Statistical Analysis

Continuous variables were compared using t-tests, and categorical variables using chi-square tests. Note that p-values of < 0.05 were considered significant. Intention-to-treat analysis was performed.

Results

Forty patients of benign GOO were evaluated (mean age 36.05 ± 1.843, 57.5% males). Subjects in the intervention arm achieved significantly more procedural and clinical success (p 0.006 and 0.010), respectively. Improvement in nutritional status was significantly more in the intervention group (hemoglobin [p 0.015]; Δ albumin [p 0.032]), while the number of mean dilations required in them were significantly lower (p 0.004). The need for bypass surgery/reconstructive surgery was significantly lower in the control group (p 0.010). The side effect profile was similar in both the groups.

Conclusion

This study concludes that addition of misoprostol along with PPI and standard endoscopic therapy significantly improves the procedural success along with clinical outcome and nutritional status while obviating the need of surgical interventions of the patient with GOO.

Keywords

gastric outlet obstruction - misoprostol - endoscopic balloon dilatation - esophageal stricture - corrosive

Authors' Contributions

Conceptualization: P.A.,M.S.,G.D., and S.N. Data curation: M.S.,G.D., and V.S.N. Formal analysis: All authors. Investigation: All authors. Methodology: P.A., G.S., G.D., and A.J. Project administration: P.A., A.J., and G.S. Resources: G.D., V.S.N., G.S., and S.N. Software: M.S., P.A., and G.S. Supervision: P.A., A.J., and S.N. Validation: P.A. and G.S. Visualization: P.A., M.S., and G.D. Writing-original draft: P.A., M.S., and V.S.N. Writing-review and editing: M.S., P.A., and G.S. All authors approved the final version of the article, including the authorship list.


Patients' Consent

Informed consent was taken from the patients.




Publikationsverlauf

Artikel online veröffentlicht:
01. Juli 2025

© 2025. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

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