Incidence of Reflux Esophagitis After Pancreaticoduodenectomy

March 22, 2011 updated by: National Taiwan University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
          • Yu-Wen Tien
        • Principal Investigator:
          • Yu-Wen Tien

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

tudy the effect of a Roux-en-Y reconstruction on GERD and marginal ulcer after pancreaticoduodenectomy

Description

Inclusion Criteria:

  • age greater than 18 years and planned PD for a lesion of either the pancreatic head or the periampullary region

Exclusion Criteria:

  • history of abdominal or pelvic radiation
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other Names:
  • Reconstruction of gastrojejunostomy
  • Roux-en-Y anastomosis versus gastrojejunostomy only
surgery, traditional gastrojejunostomy
Traditional gastrojejunostomy reconstruction (control group).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of reflux esophagitis
Time Frame: 3 months
Use panendiscopy to assess the reflux esopagitis
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidenc of marginal ulcer
Time Frame: 3 months
Use endoscopy to assess the marginal ulcer
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Yu-Wen Tien, M.D., Ph.D., Department of Surgery, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

March 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

March 8, 2011

First Submitted That Met QC Criteria

March 8, 2011

First Posted (Estimate)

March 10, 2011

Study Record Updates

Last Update Posted (Estimate)

March 23, 2011

Last Update Submitted That Met QC Criteria

March 22, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201005058R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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