Incidence of Reflux Esophagitis After Pancreaticoduodenectomy
NCT ID: NCT01311908
Last Updated: 2011-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2011-03-31
2012-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Surgery, Roux-en-Y , reflux esophagitis
Patients with roux-en-Y reconstruction (study group)
Methods of gastrojejunostomy reconstruction
Roux-en-Y reconstruction in pancreaticoduodenectomy
surgery, traditional gastrojejunostomy
Traditional gastrojejunostomy reconstruction (control group).
No interventions assigned to this group
Interventions
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Methods of gastrojejunostomy reconstruction
Roux-en-Y reconstruction in pancreaticoduodenectomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* hepatic dysfunction (Child-Pugh \> 2)
* renal dysfunction (serum creatinine concentration \> 3 mg/L, hemodialysis, or both)
* cardiac dysfunction (New York Heart Association functional class \> III, stroke history)
* pregnancy
* history of intestinal anastomosis of the large bowel without a diverting stoma
18 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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National Taiwan University Hospital
Principal Investigators
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Yu-Wen Tien, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Department of surgery, National Taiwan University Hospital
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Yu-Wen Tien
Role: primary
Other Identifiers
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201005058R
Identifier Type: -
Identifier Source: org_study_id
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