Pancreatic Cancer Clinical Trial
Official title:
A Prospective RCT Study of Distal Pancreatectomy Combined With Left Celiac Plexus Resection for Pancreatic Cancer at the Body and Tail
This is a prospective study of left celiac plexus resection for pancreatic cancer at the body and tail during standard distal pancreatectomy.
Pancreatic cancer has a property of nerve invasion. Pancreatic cancer cells first invade the
nerves within the pancreas, then reach to the retroperitoneal celiax plexus and ganglion.
Previous studies have showed nerve invasion was a negative prognostic factor for pancreatic
cancer. Celiac plexus was thought as one the sources of tumor recurrence, which also led to
severe abdominal and back pain in pancreatic cancer patients. This study is performed to
confirm whether left celiac plexus resection could improve survival and relieve pain of
pancreatic cancer patients.
Subjects undergoing surgery will be randomized to standard distal pancreatectomy plus left
celiac plexus resection versus standard distal pancreatectom. 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.The
other pre-specified outcome of pain control will be determined at one year post surgery.
Block randomization will be done using a computer generated sheet. All surgeries will be
performed under general anesthesia with epidural analgesia. The surgery will be either
performed by or under the direct supervision of pancreatic surgeons with experience in
pancreas surgery. Operative time, blood loss, blood product replacement and all
intraoperative details will be recorded in the proforma. Patients will be shifted
postoperatively to the anesthesia care unit (PACU) for observation and subsequently to the
recovery or high dependency ward once stabilized. Postoperative details including period of
postoperative pancreatic fistula,postoperative haemorrhage,postoperative pancreatitis ,
hospital stay and other complications will be recorded. Postoperative mortality will be
defined as 30-day mortality plus death before discharge after surgery.All collected data
will be entered into a statistical software package for subsequent analysis
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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