Incidence of Reflux Esophagitis After Pancreaticoduodenectomy

NCT01311908 | Unknown DMC

• 1 other identifier: 201005058R
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Reflux Esophagitis

Keywords

Pancreaticoduodenectomy; Roux-en-Y reconstruction; Reflux esophagitis

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of reflux esophagitis

  Use panendiscopy to assess the reflux esopagitis

  3 months

Secondary Outcomes (1)

• Incidenc of marginal ulcer

  3 months

Study Arms (2)

Surgery, Roux-en-Y , reflux esophagitis

Patients with roux-en-Y reconstruction (study group)

Procedure: Methods of gastrojejunostomy reconstruction

surgery, traditional gastrojejunostomy

Traditional gastrojejunostomy reconstruction (control group).

Interventions

Methods of gastrojejunostomy reconstruction PROCEDURE

Roux-en-Y reconstruction in pancreaticoduodenectomy

Also known as: Reconstruction of gastrojejunostomy, Roux-en-Y anastomosis versus gastrojejunostomy only

Surgery, Roux-en-Y , reflux esophagitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Esophagitis, Peptic

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases

Study Officials

• Yu-Wen Tien, M.D., Ph.D.

  Department of surgery, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Wen Tien, M.D., Ph.D.

CONTACT

Ywtien5106@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 8, 2011
• First Posted: March 10, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 23, 2011

Record last verified: 2011-03

Locations

TW (1)