Left Celiac Plexus Resection For Pancreatic Cancer At The Body And Tail

Study Overview

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

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

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

Pancreatic Cancer

PROCEDURE: Celiac plexus resection
PROCEDURE: Pancreatectomy

PCI002

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-04-10	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-08-10
First Submitted that Met QC Criteria 2014-04-16	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-08-11
First Posted (ESTIMATED) 2014-04-21	Results First Posted N/A	Last Verified 2016-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Single

Arms and Interventions

Participant Group/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 ly
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 ly	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 ly

Participant Group/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 ly

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 ly

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 ly

Primary Outcome Measures	Measure Description	Time Frame
Overall survival		2 years

Secondary Outcome Measures	Measure Description	Time Frame
Disease-specific, recurrence-free survival		2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Xian-Jun Yu, M.D.,Ph.D

Phone Number: +86 21 64175590

Email: yuxianjun88@hotmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

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