Reflux Esophagitis Clinical Trial
Official title:
Effect of a Roux-en-Y Reconstruction on Reflux Esophagitis After Pancreaticoduodenectomy
Reflux esophagitis is a common complication following distal gastrectomy. According to the investigators preliminary data, an Roux-en--Y gastrointestinal reconstruction in pancreaticoduodenectomy is associated with higher rates of reflux esophagitis. In this study, the investigators will investigate the incidence of reflux esophagitis after above procedure by the 24-h pH monitoring of esophagogastric junction.
Reflux esophagitis is a common complication following distal gastrectomy. Recently, an
Roux-en--Y gastrointestinal reconstruction has been used increasingly to prevent reflux
esophagitis; however, reflux esophagitis after pancreaticoduodenectomy (also including
distal gastrectomy) has never been studied.
In our preliminary retrospective study of 371 patients having PD (158 standard PD and 213
pylorus-preserving PD) at our hospital, after a median follow-up of 20 months (range, 2-110
months), 40 patients (10.8%) developed reflux esophagitis — 15 (9.5%) in the standard PD
group, and 25 (11.7%) in the PPPD group. Multivariate logistic regression analysis revealed
the only significant factors related to reflux esophagitis is Roux-en-Y gastrointestinal
reconstruction independent of preservation of the pylorus.
To our surprise, there is no significant difference in occurrence of GERD between patients
after standard PD (15 of 158 patient) and PPPD (25 of 313 patients, P=0.49). We postulate
reflux esophagitis following a PPPD in patients without past history of GERD is most likely
caused by disruption of reflux-preventing systems at the gastroesophageal junction, thereby
allowing reflux of gastric acid into esophagus. If the postulation is true, GERD after PPPD
should be acidic in nature. To test this hypothesis we propose a prospective randomized
study to compare preoperative and postoperative parameters, including esophageal morphology,
bile acid concentration, trypsin activity of esophageal refluxate, COX2 mRNA expression of
lower esophageal mucosa, and 24 hour pH monitor of lower esophagus.
Moreover, to test the effect of a Roux-en-Y reconstruction to prevent GERD after PD, studied
patients will be randomized into Roux-en-Y and control groups to study inter-group
differences in incidence of GERD and marginal ulcer after PD.
Acidic GERD should be treated with proton pump inhibitor. In contrast, alkaline GERD should
be treated with pro-kinetic agent such as primperan and mopride. With this study, we can
learn more about the nature of post-PD GERD following various gastrointestinal
reconstructions and can give patient more personalized therapy.
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Observational Model: Case Control, Time Perspective: Prospective
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