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

Study Overview

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

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.

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.

Pancreatic Cancer

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

PCI003

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 2015-08-02	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-08-10
First Submitted that Met QC Criteria 2015-08-03	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-08-11
First Posted (ESTIMATED) 2015-08-04	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: pancreatoduodenectomy & nerve resection 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 syst	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 syst
ACTIVE_COMPARATOR: 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).	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 syst PROCEDURE: 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).

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: pancreatoduodenectomy & nerve resection

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 syst

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 syst

ACTIVE_COMPARATOR: 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).

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 syst

PROCEDURE: 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).

Primary Outcome Measures	Measure Description	Time Frame
Overall survival		2 years

Secondary Outcome Measures	Measure Description	Time Frame
Pain Control	Pain control will be assess by the Visual Analogue Scale (VAS)	12 months

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: Xianjun Yu, M.D., Ph.D

Phone Number: +86 21 64175590

Email: yuxianjun@fudanpci.org

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:
1

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

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

Collaborators and Investigators

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

Publications

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