Incidence of Reflux Esophagitis After Pancreaticoduodenectomy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01311908|
Recruitment Status : Unknown
Verified March 2011 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : March 10, 2011
Last Update Posted : March 23, 2011
|Condition or disease||Intervention/treatment|
|Reflux Esophagitis||Procedure: Methods of gastrojejunostomy reconstruction|
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.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Observational Model:||Case Control|
|Official Title:||Effect of a Roux-en-Y Reconstruction on Reflux Esophagitis After Pancreaticoduodenectomy|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||March 2012|
|Estimated Study Completion Date :||December 2012|
Surgery, Roux-en-Y , reflux esophagitis
Patients with roux-en-Y reconstruction (study group)
Procedure: Methods of gastrojejunostomy reconstruction
Roux-en-Y reconstruction in pancreaticoduodenectomy
surgery, traditional gastrojejunostomy
Traditional gastrojejunostomy reconstruction (control group).
- Incidence and severity of reflux esophagitis [ Time Frame: 3 months ]Use panendiscopy to assess the reflux esopagitis
- Incidenc of marginal ulcer [ Time Frame: 3 months ]Use endoscopy to assess the marginal ulcer
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01311908
|Contact: Yu-Wen Tien, M.D., Ph.D.||Ywtien5106@ntu.edu.tw|
|National Taiwan University Hospital||Recruiting|
|Taipei, Taiwan, 100|
|Contact: Yu-Wen Tien|
|Principal Investigator: Yu-Wen Tien|
|Principal Investigator:||Yu-Wen Tien, M.D., Ph.D.||Department of surgery, National Taiwan University Hospital|