Clinical Trial: Incidence of Reflux Esophagitis After Pancreaticoduodenectomy
Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational
Official Title: Effect of a Roux-en-Y Reconstruction on Reflux Esophagitis After Pancreaticoduodenectomy
Brief Summary: 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.
Detailed Summary:
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 differen
Sponsor: National Taiwan University Hospital
Current Primary Outcome: Incidence and severity of reflux esophagitis [ Time Frame: 3 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Incidenc of marginal ulcer [ Time Frame: 3 months ]
Original Secondary Outcome: Same as current
Information By: National Taiwan University Hospital
Dates:
Date Received: March 8, 2011
Date Started: March 2011
Date Completion: December 2012
Last Updated: March 22, 2011
Last Verified: March 2011
