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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02117895
• Other study ID #: PCI002
• Status: Recruiting
• Phase: Phase 3
• First received: April 10, 2014
• Last updated: August 10, 2016
• Start date: January 2014
• Est. completion date: January 2017

Study information

• Verified date: August 2016
• Source: Fudan University
• Contact: Xian-Jun Yu, M.D.,Ph.D
• Phone: +86 21 64175590
• Email: yuxianjun88[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• 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).

Locations

Country	Name	City	State
China	Xian-Jun Yu	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

References & 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. — View Citation

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. Review. Japanese. — View Citation

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 — View Citation

Yamamoto M, Ohashi O, Saitoh Y. Japan Pancreatic Cancer Registry: current status. Pancreas. 1998 Apr;16(3):238-42. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain Control	Paint control will be assess by the Visual Analogue Scale (VAS)	12 months	No
Primary	Overall survival		2 years	No
Secondary	Disease-specific, recurrence-free survival		2 years	No