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临床试验/NCT03984734
NCT03984734已完成不适用

Randomized Trial Comparing Quality of Life and Nutritional Status Between Pylorus-preserving Pancreatoduodenectomy Versus Standard Pancreatoduodenectomy (QUANUPAD TRIAL)

Hospital Universitari de Bellvitge0 个研究点目标入组 80 人开始时间: 2003年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
主要终点
Incidence and severity of DGE

研究概览

简要总结

This was a randomized unblinded single-centre trial. The main hypothesis of the study was that pylorus-preserving pancreatoduodenectomy reduces the incidence of delayed gastric emptying . Patients undergoing pancreatoduodenectomy were randomized to undergo one of two types of surgical technique: pylorus-preserving pancreatoduodenectomy versus stardard pancreatoduodenectomy with antrectomy. The primary endpoint was the incidence and severity of delayed gastric emptying. Secondary endpoints were postoperative morbidity and mortality, length of hospital stay, and nutritional status and quality of life.

详细描述

This was a randomized unblinded single-centre trial without masked evaluation of the main outcome.The authors decided to compare pancreatoduodenectomy with antrectomy versus pancreatoduodenectomy with pyloric preservation. The primary aim of this randomized clinical trial was to determine whether pancreatoduodenectomy with pyloric preservation is associated with a lower incidence and severity of delayed gastric emptying. Secondary endpoints were postoperative complications, postoperative mortality and duration of hospital stay. Patients undergoing pancreatoduodenectomy were randomized to undergo one of two types of gastroenteric anastomosis for reconstruction. Analytical parameters such as C-reactive protein, prealbumin, and albumin; as well as anthropometric measures (mean) as preoperative arm circumference mean and tricipital skinfold mean were registered preoperatively, at 5th week, and at 6th mounth. Scintigraphic study had performed following a specific protocol for gastric emptying. At the end, quality of life was also analized with a quality of life questionnaire (QLPAN26) preoperativelly and postoperatively.

研究设计

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

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

  • Patients who underwent surgical resection of the head of the pancreas at the authors' institution from August 2003 to August
  • Adults of either sex aged over 18 years were included.

排除标准

  • Associated resections of other organs, except for the portal or superior mesenteric vein
  • Total pancreatectomy
  • Previous gastrectomy or other gastric surgeries
  • Neoadjuvant treatment
  • Liver cirrhosis.

研究组 & 干预措施

Control group

Active Comparator

Patients undergoing pancreatoduodenectomy with antrectomy

干预措施: Pancreatoduodenectomy with antrectomy (Procedure)

Study group

Experimental

Patients undergoing pancreatoduodenectomy with pylorus-preserving pancreatoduodenectomy

干预措施: Pylorus-preserving pancreatoduodenectomy (Procedure)

结局指标

主要结局

Incidence and severity of DGE

时间窗: within the first 90 days after surgery

Nasogastric tube not removed before the 10th postoperative days or if liquids were not tolerated before the 14th postoperative day

次要结局

  • Postoperative morbidity(within the first 90 days after surgery)
  • Postoperative mortality(within the first 90 days after surgery)
  • Length of hospital stay(within the first 90 days after surgery)

研究者

发起方
Hospital Universitari de Bellvitge
申办方类型
Other
责任方
Principal Investigator
主要研究者

BUSQUETS, JULI

Staff surgeon Bellvitge Universitary Hospital

Hospital Universitari de Bellvitge

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