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临床试验/NCT02635399
NCT02635399Unknown不适用

Impact of Additional DJ (Duodenojejunostomy)-Pexy on Reduction in Delayed Gastric Emptying Following Pylorus-preserving Pancreaticoduodenectomy: A Prospective, Randomized Controlled Trial

Yonsei University2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
78
试验地点
2
主要终点
Occurence of clinically relevant DGE

研究概览

简要总结

Surgical resection in periampullary cancer using pancreaticoduodenectomy is the most important modality in the treatment. In the past, pancreaticoduodenectomy was associated with high morbidity and mortality. However, with the advances in techniques, including perioperative patient management, development of antibiotics, diagnostic radiology, and interventional treatments, pancreaticoduodenectomy is now considered a safe and feasible operation. Postoperative complication rates are reported to be in 10 to 20% in experienced hospitals and operation related mortality is at about 1%. Therefore, surgical treatment for periampullary cancer is actively considered.

However, postoperative complications, such as postoperative pancreatic fistula, (POPF) delayed gastric emptying, intraabdominal abscess, and postoperative bleeding, are still serious complications. Among these complications, delayed gastric emptying is considered less critical. However, delayed gastric emptying (DGE) can cause poor oral intake, which in turn, may lead to delay in recovery of postoperative nutritional state and in severe cases, requires insertion of levine tube and long-term fasting.

There have been many hypotheses for cause of DGE after pancreaticoduodenectomy, but definite cause have not been discovered yet. With the introduction of pylorus-preserving pancreaticoduodenectomy (PPPD), incidences of DGE were initially reported to have increased. However, results of most randomized comparative studies had concluded that PPPD and PD have no significance in occurence of DGE.

One hypothesis for cause of DGE we present here has to do with anatomic positioning of anastomosis site, especially pancreatojejunostomy (PJ) and duodenojejunostomy (DJ), after PPPD. Reconstruction after PPPD positions PJ and DJ close to each other. PJ site is often associated with one of postoperative complications, POPF. POPF may create inflammation around PJ site and pancreatitis, which may lead to severe adhesion around PJ as a secondary change. This adhesion and inflammation may cause DJ, which is located near PJ, to be pulled towards PJ site. When DJ is pulled towards PJ site, distal DJ site can become angulated and gastric contents may not beadle to pass easily. Gastric contents may be stagnated in stomach and thereby causing DGE. Therefore, in this study, we will fixate DJ on transverse colon using sutures, and prevent possibility of angulation of DJ. This additional procedure may reduce occurence of DGE.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All periampullary pathologic conditions that require PPPD
  • Age ≥20 and ≤80
  • General performance status: the Karnofsky score> 70% or ECOG 0-1

排除标准

  • Unresectable or locally advanced, metastatic case
  • patients who do not want surgery
  • ASA (American society of anesthesiologists' physical status classification) score: ≥3
  • patients with drug or alcohol addiction
  • patients showing low compliance
  • patients who not want to involve the clinical trial
  • patients who are unable to read or understand the informed consent, sign a consent form (eg, mental retardation, blindness, illiteracy, foreign, etc.)
  • pylorus can not be preserved
  • Patients undergoing laparoscopic PPPD
  • Additional resection of adjacent organs or vascular resection was performed
  • Previous history of open surgery

研究组 & 干预措施

conventional group

Placebo Comparator

Conventional PPPD

干预措施: PPPD (pylorus-preserving pancreaticoduodenectomy) (Procedure)

DJ-pexy group

Experimental

PPPD with additional DJ-pexy to anchor DJ to transverse colon

干预措施: PPPD (pylorus-preserving pancreaticoduodenectomy) with DJ-pexy (Procedure)

结局指标

主要结局

Occurence of clinically relevant DGE

时间窗: With the first 30days after surgery

DGE is defined by International Study Group of Pancreatic Surgery consensus definition. Clinically relevant grade B or C will be recorded and occurrence rate of DGE between the arms will be compared.

次要结局

  • Risk factors influencing DGE(Within the first 30 days after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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