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临床试验/NCT01311908
NCT01311908Unknown不适用

Effect of a Roux-en-Y Reconstruction on Reflux Esophagitis After Pancreaticoduodenectomy

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Incidence and severity of reflux esophagitis

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Incidence and severity of reflux esophagitis

时间窗: 3 months

Use panendiscopy to assess the reflux esopagitis

次要结局

  • Incidenc of marginal ulcer(3 months)

研究者

申办方类型
Other

研究点 (1)

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