Clinical trialPhase 3Unknown
Left Celiac Plexus Resection for Pancreatic Cancer at the Body and Tail
A Prospective RCT Study of Distal Pancreatectomy Combined With Left Celiac Plexus Resection for Pancreatic Cancer at the Body and Tail
- Outcome
- Outcome unknown
- Phase
- Phase 3
- Status
- Unknown
- Study type
- Interventional
- Start
- January 2014
- Expected end
- January 2017
- Enrollment
- 180 participants
- Sites
- 1
- Primary outcomes
- Overall survival
- Sponsor
- Other
- Results posted
- No
- Last update
- 11 August 2016
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Brief summary public domain (ClinicalTrials.gov)
This is a prospective study of left celiac plexus resection for pancreatic cancer at the body and tail during standard distal pancreatectomy.
Detailed description public domain (ClinicalTrials.gov)
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
Papers 4
- BackgroundJapan Pancreatic Cancer Registry; 30th year anniversary: Japan Pancreas Society. DOI 10.1097/mpa.0b013e318258055c↗
- BackgroundRandomized, double-blind, controlled trial of early endoscopic ultrasound-guided celiac plexus neurolysis to prevent pa… DOI 10.1200/jco.2010.32.2750↗
- Background[Standard surgery as part of the multidisciplinary treatment for pancreatic cancer]. PMID 16878410↗
- BackgroundJapan Pancreatic Cancer Registry: current status. DOI 10.1097/00006676-199804000-00006↗