Left Celiac Plexus Resection for Pancreatic Cancer at the Body and Tail
NCT ID: NCT02117895
Last Updated: 2016-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
180 participants
INTERVENTIONAL
2014-01-31
2017-01-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Celiac plexus resection
Celiac plexus at the left side of aorta, between celiac trunk and superior mesenteric artery will be resected.
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).
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).
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).
Interventions
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Celiac plexus resection
Celiac plexus at the left side of aorta, between celiac trunk and superior mesenteric artery will be resected.
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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Xian-Jun Yu
Professor and Chair,Department of Pancreatic & Hepatobiliary Surgery
Principal Investigators
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Xian-Jun Yu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Principal Investigator
Locations
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Xian-Jun Yu
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Fujii 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.
Yamamoto M, Ohashi O, Saitoh Y. Japan Pancreatic Cancer Registry: current status. Pancreas. 1998 Apr;16(3):238-42. doi: 10.1097/00006676-199804000-00006.
Wyse 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.
Other Identifiers
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PCI002
Identifier Type: -
Identifier Source: org_study_id
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