Resection of the Nerve Plexus on the Right Half of Celiac and SMA Associated With Extended Pancreatoduodenectomy in the Surgical Treatment for Adenocarcinoma of the Head of Pancreas

Pancreatic Cancer Clinical Trial

Official title:

Resection of the Nerve Plexus on the Right Half of Celiac and SMA Associated With Extended Pancreatoduodenectomy in the Surgical Treatment for Adenocarcinoma of the Head of Pancreas

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02514928
• Other study ID #: PCI003
• Status: Recruiting
• Phase: Phase 3
• First received: August 2, 2015
• Last updated: August 10, 2016
• Start date: June 2015
• Est. completion date: June 2019

Study information

• Verified date: August 2016
• Source: Fudan University
• Contact: Xianjun Yu, M.D., Ph.D
• Phone: +86 21 64175590
• Email: yuxianjun[@]fudanpci.org
• Is FDA regulated: No
• Health authority: China: Chinese Medical AssociationChina: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This study is performed to confirm whether resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy could improve survival and relieve pain of pancreatic cancer patients.

Description:

Lymph node metastasis and nerve invasion are characteristics of pancreatic cancer. For pancreatic head cancer, celiac and SMA nerve plexus are often involved. Many surgeons started to improve the surgical approach of pancreatoduodenectomy by extending the extent of surgical resection including an extended lymph node dissection and nerve plexus clearance in the hope of achieving better long-term survival rate. Postoperative complications such as diarrhea and malnutrition were reported after celiac and SMA nerve plexus resection during pancreatoduodenectomy. As a result, resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy was recommended. This study is performed to confirm whether resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy could improve survival and relieve pain of pancreatic cancer patients.

Subjects undergoing surgery will be randomized to extended pancreatoduodenectomy with resection of the nerve plexus on the right half of celiac and SMA versus standard pancreatoduodenectomy. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 430
• Est. completion date: June 2019
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• 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 head 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 body and tail of the pancreas

• Benign tumor at the head 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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy
Resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy. Regional lymph nodes includes group 5,6,8a,8p,9,12a,12b,12c,12p,13,14a,14b,14c,16,17, according to the 2003 edition of lymph nodes group system defined by Japan Pancreas Society (JPS).
• standard pancreatoduodenectomy
Standard pancreatoduodenectomy with regional lymph nodes includes group 5,6,8a,12b,12c,13,14a,14b,17, according to the 2003 edition of lymph nodes group system defined by Japan Pancreas Society (JPS).

Locations

Country	Name	City	State
China	Pancreatic Cancer Institute	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		2 years	No
Secondary	Pain Control	Pain control will be assess by the Visual Analogue Scale (VAS)	12 months	No