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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.
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.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
Yes
Pancreatic Cancer Institute
Shanghai, Shanghai Municipality, China
Start Date
June 1, 2015
Primary Completion Date
June 1, 2017
Completion Date
June 1, 2019
Last Updated
August 11, 2016
430
ESTIMATED participants
resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy
PROCEDURE
standard pancreatoduodenectomy
PROCEDURE
Lead Sponsor
Fudan University
NCT04550494
NCT05053971
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