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
1 other identifier
interventional
180
1 country
1
Brief Summary
This is a prospective study of left celiac plexus resection for pancreatic cancer at the body and tail during standard distal pancreatectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 pancreatic-cancer
Started Jan 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 10, 2014
CompletedFirst Posted
Study publicly available on registry
April 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedAugust 11, 2016
August 1, 2016
3 years
April 10, 2014
August 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
2 years
Secondary Outcomes (1)
Disease-specific, recurrence-free survival
2 years
Other Outcomes (1)
Pain Control
12 months
Study Arms (2)
Pancreatectomy & celiac plexus resection
EXPERIMENTALLeft 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.
Pancreatectomy
ACTIVE COMPARATORStandard 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).
Interventions
Celiac plexus at the left side of aorta, between celiac trunk and superior mesenteric artery will be resected.
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Xian-Jun Yu
Shanghai, 200032, China
Related Publications (4)
Egawa S, Toma H, Ohigashi H, Okusaka T, Nakao A, Hatori T, Maguchi H, Yanagisawa A, Tanaka M. Japan Pancreatic Cancer Registry; 30th year anniversary: Japan Pancreas Society. Pancreas. 2012 Oct;41(7):985-92. doi: 10.1097/MPA.0b013e318258055c.
PMID: 22750974RESULTFujii Y, Ueda M, Yoshida K, Matsuo K, Takeda K, Morioka D, Tanaka K, Endo I, Togo S, Shimada H. [Standard surgery as part of the multidisciplinary treatment for pancreatic cancer]. Nihon Geka Gakkai Zasshi. 2006 Jul;107(4):177-81. Japanese.
PMID: 16878410RESULTYamamoto M, Ohashi O, Saitoh Y. Japan Pancreatic Cancer Registry: current status. Pancreas. 1998 Apr;16(3):238-42. doi: 10.1097/00006676-199804000-00006.
PMID: 9548661RESULTWyse JM, Carone M, Paquin SC, Usatii M, Sahai AV. Randomized, double-blind, controlled trial of early endoscopic ultrasound-guided celiac plexus neurolysis to prevent pain progression in patients with newly diagnosed, painful, inoperable pancreatic cancer. J Clin Oncol. 2011 Sep 10;29(26):3541-6. doi: 10.1200/JCO.2010.32.2750. Epub 2011 Aug 15.
PMID: 21844506RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xian-Jun Yu, M.D.
Principal Investigator
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Chair,Department of Pancreatic & Hepatobiliary Surgery
Study Record Dates
First Submitted
April 10, 2014
First Posted
April 21, 2014
Study Start
January 1, 2014
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
August 11, 2016
Record last verified: 2016-08