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

NCT02514928 | Unknown Phase 3 DMC

• 1 other identifier: PCI003
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

  2 years

Secondary Outcomes (1)

• Pain Control

  12 months

Study Arms (2)

pancreatoduodenectomy & nerve resection

EXPERIMENTAL

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).

Procedure: resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy

pancreatoduodenectomy

ACTIVE COMPARATOR

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).

Procedure: standard pancreatoduodenectomy

Interventions

resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy PROCEDURE

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).

pancreatoduodenectomy & nerve resection

standard pancreatoduodenectomy PROCEDURE

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).

pancreatoduodenectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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 head 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 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Pancreatic Cancer Institute

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Xianjun Yu, M.D., Ph.D

CONTACT

+86 21 64175590; yuxianjun@fudanpci.org

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

Study Record Dates

• First Submitted: August 2, 2015
• First Posted: August 4, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2019
• Last Updated: August 11, 2016

Record last verified: 2016-08

Locations

CN (1)