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

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ClinicalTrials.gov Identifier: NCT02117895
Recruitment Status : Unknown
Verified August 2016 by Xian-Jun Yu, Fudan University.
Recruitment status was:  Recruiting
First Posted : April 21, 2014
Last Update Posted : August 11, 2016
Sponsor:
Information provided by (Responsible Party):
Xian-Jun Yu, Fudan University

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

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Procedure: Celiac plexus resection Procedure: Pancreatectomy Phase 3

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective RCT Study of Distal Pancreatectomy Combined With Left Celiac Plexus Resection for Pancreatic Cancer at the Body and Tail
Study Start Date : January 2014
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pancreatectomy & celiac plexus resection
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.
Procedure: Celiac plexus resection
Celiac plexus at the left side of aorta, between celiac trunk and superior mesenteric artery will be resected.

Procedure: Pancreatectomy
Standard distal pancreatectomy includes distal pancreatectomy, splenectomy, and regional lymph nodes resection for pancreatic cancer at the body and tail. Regional lymph nodes includes group 8, 10, 11, 18, 7, 9, 14, 15, according to the 2003 edition of lymph nodes group system defined by Japan Pancreas Society (JPS).

Active Comparator: Pancreatectomy
Standard distal pancreatectomy includes distal pancreatectomy, splenectomy, and regional lymph nodes resection for pancreatic cancer at the body and tail. Regional lymph nodes includes group 8, 10, 11, 18, 7, 9, 14, 15, according to the 2003 edition of lymph nodes group system defined by Japan Pancreas Society (JPS).
Procedure: Pancreatectomy
Standard distal pancreatectomy includes distal pancreatectomy, splenectomy, and regional lymph nodes resection for pancreatic cancer at the body and tail. Regional lymph nodes includes group 8, 10, 11, 18, 7, 9, 14, 15, according to the 2003 edition of lymph nodes group system defined by Japan Pancreas Society (JPS).




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Disease-specific, recurrence-free survival [ Time Frame: 2 years ]

Other Outcome Measures:
  1. Pain Control [ Time Frame: 12 months ]
    Paint control will be assess by the Visual Analogue Scale (VAS)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02117895


Contacts
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Contact: Xian-Jun Yu, M.D.,Ph.D +86 21 64175590 ext 1305 yuxianjun88@hotmail.com

Locations
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China
Xian-Jun Yu Recruiting
Shanghai, China, 200032
Contact: Guo-Pei Luo, M.D.    +86 21 64175590 ext 1305    luoguopei@gmail.com   
Principal Investigator: Xian-Jun Yu, M.D.         
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Xian-Jun Yu, M.D. Principal Investigator

Publications of Results:
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Responsible Party: Xian-Jun Yu, Professor and Chair,Department of Pancreatic & Hepatobiliary Surgery, Fudan University
ClinicalTrials.gov Identifier: NCT02117895     History of Changes
Other Study ID Numbers: PCI002
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016
Keywords provided by Xian-Jun Yu, Fudan University:
Distal Pancreatectomy
Celiac Plexus
Resection
Pancreatic Cancer
Body and Tail
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases