Pancreatic Cancer Clinical Trial
Official title:
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
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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