Left Celiac Plexus Resection for Pancreatic Cancer at the Body and Tail

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Brief Title

Left Celiac Plexus Resection for Pancreatic Cancer at the Body and Tail

Official Title

A Prospective RCT Study of Distal Pancreatectomy Combined With Left Celiac Plexus Resection for Pancreatic Cancer at the Body and Tail

Brief Summary

      This is a prospective study of left celiac plexus resection for pancreatic cancer at the body
      and tail during standard distal pancreatectomy.
    

Detailed Description

      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
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Overall survival

Secondary Outcome

 Disease-specific, recurrence-free survival

Condition

Pancreatic Cancer

Intervention

Celiac plexus resection

Study Arms / Comparison Groups

 Pancreatectomy & celiac plexus resection
Description:  Left celiac plexus resection will be performed besides standard distal pancreatectomy. Celiac plexus at the left side of aorta, between celiac trunk and superior mesenteric artery will be resected.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

180

Start Date

January 2014

Completion Date

January 2017

Primary Completion Date

January 2017

Eligibility Criteria

        Inclusion Criteria:

          -  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 body and tail of the pancreas without distant metastasis

          -  No celiac trunk and superior mesenteric artery invasion by Loyer grading

          -  No operation contraindication

        Exclusion Criteria:

          -  The pathological staging exceed the stage IIB

          -  Pancreatic cancer at the head of the pancreas

          -  Benign tumor at the body and tail 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
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Xian-Jun Yu, M.D., +86 21 64175590, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT02117895

Organization ID

PCI002


Responsible Party

Principal Investigator

Study Sponsor

Fudan University


Study Sponsor

Xian-Jun Yu, M.D., Principal Investigator, Principal Investigator


Verification Date

August 2016