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Peer-reviewedCC BY 4.0PLOS One

Protocol of the PANEM trial: A randomized, phase III, parallel-arm, placebo-controlled, double-blind, multi-center superiority trial comparing PANcreatic EnzyMes versus placebo in adults after gastrectomy

  • Kevin Thomas1
  • Charlotte Ackmann2
  • Anett Schmiedeknecht3
  • Kathrin Scheibe4
  • Tobias Kleemann5
  • Michael Ardelt6
  • Felix Dondorf7
  • Olga Radulova-Mauersberger8
  • Jasmina Kuvendjiska9
  • Julian Hipp10
  • Boris Jansen-Winkeln
  • Thomas Bley
7 more authors
  • Ulrike Wetzold
  • Judith Sporn
  • Franziska Peters
  • Patrick Téoule
  • Emrullah Birgin
  • David Petroff
  • Albrecht Hoffmeister
10 affiliations
  1. 1Department of Medicine, Neurology and Dermatology, Division of Oncology, Gastroenterology, Hepatology and Pneumology, Leipzig University Medical Center, Leipzig, Germany
  2. 2Clinical Trial Centre Leipzig, Leipzig University, Medical faculty, Leipzig, Germany
  3. 34th Medical Clinic for Gastroenterology and Rheumatology, Medical University of Lausitz - Carl Thiem, Cottbus, Germany
  4. 4Department of General, Visceral and Vascular Surgery, University Hospital Jena, Jena, Germany
  5. 5Department of Visceral, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Dresden, Dresden, Germany
  6. 6Department of General and Visceral Surgery, University Medical Center Freiburg, Freiburg, Germany
  7. 7Department of General, Visceral, Thoracic and Vascular Surgery, St. George’s Hospital Leipzig, Leipzig, Germany
  8. 8Department of Surgery, Medical University of Lausitz - Carl Thiem, Cottbus, Germany
  9. 9Department of General and Visceral Surgery, Helios Hospital Schwerin, Schwerin, Germany
  10. 10Department of General and Visceral Surgery, University Hospital Ulm, Ulm, Germany
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Abstract

Background: Patients after partial or total gastrectomy suffer from malnourishment and diminished quality of life (QOL). Due to altered physiological processes after gastric surgery, coordination between chyme and digestive enzymes produced by the pancreas is affected in many ways, finally leading to maldigestion and malabsorption. These in turn promote various symptoms such as discomfort or steatorrhea. Supplementation of digestive enzymes during food intake may improve digestion and decrease nutrition-related abdominal symptoms, finally leading to higher QOL. To date, trials examining the role of digestive enzyme supplementation in patients with gastrectomy are lacking. Methods: We designed a randomized, phase III, parallel-arm, placebo-controlled, double-blind, multi-center superiority trial comparing QOL after 6 months of oral digestive enzyme supplementation vs. placebo in a sample of 188 patients after partial or total gastrectomy. Digestive enzymes or placebo are taken orally with the meals. Cancer specific QOL (physical sub-score from EORTC-QLQ-C30) at six months is the primary outcome. Secondary outcomes include other measures of QOL, weight loss, use of supplemental nutrition, and laboratory measurements related to malnutrition and metabolism. Discussion: This trial will help assess using digestive enzymes in patients with partial or total gastrectomy. Trial Registration: EU Trial Number: 2022-501944-14-00. Clinical Trial Number: NCT06058442 (Registration date: 09/08/2023).

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Cite

BibTeXRIS
BibTeX
@article{thomas2026protocol,
  title = {{Protocol of the PANEM trial: A randomized, phase III, parallel-arm, placebo-controlled, double-blind, multi-center superiority trial comparing PANcreatic EnzyMes versus placebo in adults after gastrectomy}},
  author = {Kevin Thomas and Charlotte Ackmann and Anett Schmiedeknecht and Kathrin Scheibe and Tobias Kleemann and Michael Ardelt and Felix Dondorf and Olga Radulova-Mauersberger and Jasmina Kuvendjiska and Julian Hipp and Boris Jansen-Winkeln and Thomas Bley and Ulrike Wetzold and Judith Sporn and Franziska Peters and Patrick Téoule and Emrullah Birgin and David Petroff and Albrecht Hoffmeister},
  journal = {PLOS One},
  year = {2026},
  month = sep,
  doi = {10.1371/journal.pone.0358177},
  url = {https://doi.org/10.1371/journal.pone.0358177},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Protocol of the PANEM trial: A randomized, phase III, parallel-arm, placebo-controlled, double-blind, multi-center superiority trial comparing PANcreatic EnzyMes versus placebo in adults after gastrectomy
AU  - Kevin Thomas
AU  - Charlotte Ackmann
AU  - Anett Schmiedeknecht
AU  - Kathrin Scheibe
AU  - Tobias Kleemann
AU  - Michael Ardelt
AU  - Felix Dondorf
AU  - Olga Radulova-Mauersberger
AU  - Jasmina Kuvendjiska
AU  - Julian Hipp
AU  - Boris Jansen-Winkeln
AU  - Thomas Bley
AU  - Ulrike Wetzold
AU  - Judith Sporn
AU  - Franziska Peters
AU  - Patrick Téoule
AU  - Emrullah Birgin
AU  - David Petroff
AU  - Albrecht Hoffmeister
PY  - 2026
DA  - 2026/09/22
JO  - PLOS One
DO  - 10.1371/journal.pone.0358177
UR  - https://doi.org/10.1371/journal.pone.0358177
AB  - Background: Patients after partial or total gastrectomy suffer from malnourishment and diminished quality of life (QOL). Due to altered physiological processes after gastric surgery, coordination between chyme and digestive enzymes produced by the pancreas is affected in many ways, finally leading to maldigestion and malabsorption. These in turn promote various symptoms such as discomfort or steatorrhea. Supplementation of digestive enzymes during food intake may improve digestion and decrease nutrition-related abdominal symptoms, finally leading to higher QOL. To date, trials examining the role of digestive enzyme supplementation in patients with gastrectomy are lacking. Methods: We designed a randomized, phase III, parallel-arm, placebo-controlled, double-blind, multi-center superiority trial comparing QOL after 6 months of oral digestive enzyme supplementation vs. placebo in a sample of 188 patients after partial or total gastrectomy. Digestive enzymes or placebo are taken orally with the meals. Cancer specific QOL (physical sub-score from EORTC-QLQ-C30) at six months is the primary outcome. Secondary outcomes include other measures of QOL, weight loss, use of supplemental nutrition, and laboratory measurements related to malnutrition and metabolism. Discussion: This trial will help assess using digestive enzymes in patients with partial or total gastrectomy. Trial Registration: EU Trial Number: 2022-501944-14-00. Clinical Trial Number: NCT06058442 (Registration date: 09/08/2023).
SN  - 1932-6203
ER  -