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临床试验/NCT02514928
NCT02514928Unknown3 期

Resection of the Nerve Plexus on the Right Half of Celiac and SMA Associated With Extended Pancreatoduodenectomy in the Surgical Treatment for Adenocarcinoma of the Head of Pancreas

Fudan University1 个研究点 分布在 1 个国家目标入组 430 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
3 期
入组人数
430
试验地点
1
主要终点
Overall survival

研究概览

简要总结

This study is performed to confirm whether resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy could improve survival and relieve pain of pancreatic cancer patients.

详细描述

Lymph node metastasis and nerve invasion are characteristics of pancreatic cancer. For pancreatic head cancer, celiac and SMA nerve plexus are often involved. Many surgeons started to improve the surgical approach of pancreatoduodenectomy by extending the extent of surgical resection including an extended lymph node dissection and nerve plexus clearance in the hope of achieving better long-term survival rate. Postoperative complications such as diarrhea and malnutrition were reported after celiac and SMA nerve plexus resection during pancreatoduodenectomy. As a result, resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy was recommended. This study is performed to confirm whether resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy could improve survival and relieve pain of pancreatic cancer patients.

Subjects undergoing surgery will be randomized to extended pancreatoduodenectomy with resection of the nerve plexus on the right half of celiac and SMA versus standard pancreatoduodenectomy. Subjects will be followed every two months for survivorship or death to assess pain, quality of life measures, and narcotic pain control usage. The primary endpoint of overall survival and the secondary endpoint of disease-specific free survival will be determined at two year post surgery.

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
Single (Participant)

入排标准

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

入选标准

  • Signed informed content obtained prior to treatment
  • Age ≥ 18 years and ≤ 80 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • The pathological staging does not exceed the stage IIB
  • The expected survival after surgery ≥ 3 months
  • Tumor locates at the head of the pancreas without distant metastasis
  • No celiac trunk and superior mesenteric artery invasion by Loyer grading
  • No operation contraindication

排除标准

  • The pathological staging exceed the stage IIB
  • Pancreatic cancer at the body and tail of the pancreas
  • Benign tumor at the head of the pancreas
  • Distant metastasis
  • Severe important organ function impairment
  • Active second primary malignancy or history of second primary malignancy within the last 3 years
  • Pregnant or nursing women
  • Human immunodeficiency virus (HIV)-positive patients
  • Patients who are unwilling or unable to comply with study procedures

结局指标

主要结局

Overall survival

时间窗: 2 years

次要结局

  • Pain Control(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xian-Jun Yu

Professor

Fudan University

研究点 (1)

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