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

Fudan University

Status and phase: Unknown; Phase 3

Conditions: Pancreatic Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02514928

PCI003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 430 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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430 participants in 2 patient groups

pancreatoduodenectomy & nerve resection

Experimental group

Description:

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).

Treatment:

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

pancreatoduodenectomy

Active Comparator group

Description:

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).

Treatment:

Procedure: standard pancreatoduodenectomy