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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

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ClinicalTrials.gov Identifier: NCT02514928
Recruitment Status : Recruiting
First Posted : August 4, 2015
Last Update Posted : August 11, 2016
Sponsor:
Information provided by (Responsible Party):
Xian-Jun Yu, Fudan University

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Procedure: resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy Procedure: standard pancreatoduodenectomy Phase 3

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 430 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : June 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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 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 system defined by Japan Pancreas Society (JPS).

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: 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 :
  1. Overall survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Pain Control [ Time Frame: 12 months ]
    Pain control will be assess by the Visual Analogue Scale (VAS)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02514928


Contacts
Contact: Xianjun Yu, M.D., Ph.D +86 21 64175590 ext 1305 yuxianjun@fudanpci.org

Locations
China, Shanghai
Pancreatic Cancer Institute Recruiting
Shanghai, Shanghai, China, 200032
Contact: Yu Lu    +86 21 64175590 ext 1305    luyu@fudanpci.org   
Principal Investigator: Xianjun Yu, M.D         
Sponsors and Collaborators
Fudan University

Responsible Party: Xian-Jun Yu, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT02514928     History of Changes
Other Study ID Numbers: PCI003
First Posted: August 4, 2015    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancrelipase
Pancreatin
Gastrointestinal Agents