Incidence of Reflux Esophagitis After Pancreaticoduodenectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01311908
First received: March 8, 2011
Last updated: March 22, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Reflux Esophagitis
Procedure: Methods of gastrojejunostomy reconstruction

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effect of a Roux-en-Y Reconstruction on Reflux Esophagitis After Pancreaticoduodenectomy

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Incidence and severity of reflux esophagitis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Use panendiscopy to assess the reflux esopagitis


Secondary Outcome Measures:
  • Incidenc of marginal ulcer [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Use endoscopy to assess the marginal ulcer


Biospecimen Retention:   Samples With DNA

esophageal mucosal biopsy for Real-Time PCR for COX-2 activity


Estimated Enrollment: 50
Study Start Date: March 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01311908

Contacts
Contact: Yu-Wen Tien, M.D., Ph.D. Ywtien5106@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Yu-Wen Tien         
Principal Investigator: Yu-Wen Tien         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Yu-Wen Tien, M.D., Ph.D. Department of surgery, National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Tien Yu-Wen, M.D., Ph.D., National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01311908     History of Changes
Other Study ID Numbers: 201005058R
Study First Received: March 8, 2011
Last Updated: March 22, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Pancreaticoduodenectomy
Roux-en-Y reconstruction
Reflux esophagitis

Additional relevant MeSH terms:
Esophagitis
Esophagitis, Peptic
Gastroesophageal Reflux
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Esophageal Motility Disorders
Deglutition Disorders

ClinicalTrials.gov processed this record on August 28, 2014