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Randomized Trial of Pylorus-Preserving vs. Pylorus-Resecting Pancreatoduodenectomy: Long-Term Morbidity and Quality of Life

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Journal of Gastrointestinal Surgery Aims and scope

Abstract

Background

The randomized controlled PROPP trial (DKRS00004191) showed that pylorus-resecting pancreatoduodenectomy (PR) is not superior to the pylorus-preserving procedure (PP) in terms of perioperative outcome, specifically in reduction of delayed gastric emptying. Non-superiority of PR was also confirmed in a recent meta-analysis of randomized controlled trials. However, long-term data on morbidity and quality of life after PP compared to PR are sparse. The aim of this study was to investigate long-term outcomes of patients included in the PROPP trial.

Methods

Between February 2013 and June 2016, a total of 188 patients underwent PD and were intraoperatively randomized to either preservation or resection of the pylorus (95 vs. 93 patients). For long-term follow-up, morbidity and quality of life (EORTC QLQ-C30/PAN26) were monitored until January 1, 2018. Statistical analysis was performed on an intention-to-treat basis.

Results

The mean duration of follow-up was 34.3 (± 11.3) months. Sixty-three of the 188 patients had died (PP n = 33, PR n = 30), 29 patients were lost to follow-up (PP n = 17, PR n = 12), and the remaining 96 patients were included in long-term follow-up (PP n = 45, PR n = 51). There was no difference between PP and PR patients regarding endocrine and exocrine pancreatic function, receipt of adjuvant/palliative chemotherapy, cancer recurrence, and other relevant characteristics. Late cholangitis occurred significantly more often in patients following pylorus resection (P = 0.042). Reoperations, readmissions to hospital, and quality of life scores except pain were comparable between the two study groups.

Conclusions

Similar to short-term results, long-term follow-up showed no significant differences between pylorus resection compared to pylorus preservation.

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Authors and Affiliations

  1. Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany

    Ulla Klaiber, Pascal Probst, Felix J. Hüttner, Oliver Strobel, Markus K. Diener, André L. Mihaljevic, Markus W. Büchler & Thilo Hackert

  2. Institute of Medical Biometry and Informatics, University of Heidelberg, Im Neuenheimer Feld 130, 69120 Heidelberg, Germany

    Thomas Bruckner

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  1. Ulla Klaiber
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Contributions

TH and UK conceived and designed the study. UK, ALM, PP, and FJH were involved in the acquisition, analysis, and interpretation of data. UK drafted the manuscript. UK and TB designed the tables and figures. TH, MWB, ALM, MD, TB, and OS participated in the design and conduct of the study and revised the manuscript. TB was involved in the conception of the statistical analysis plan and the final analysis. All authors revised the manuscript critically for important intellectual content and approved the version to be published.

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Correspondence to Thilo Hackert.

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Klaiber, U., Probst, P., Hüttner, F.J. et al. Randomized Trial of Pylorus-Preserving vs. Pylorus-Resecting Pancreatoduodenectomy: Long-Term Morbidity and Quality of Life. J Gastrointest Surg 24, 341–352 (2020). https://doi.org/10.1007/s11605-018-04102-y

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