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

Phase 3

• Conditions: Pancreatic Cancer
• Interventions: Procedure: resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy; Procedure: standard pancreatoduodenectomy

• Registration Number: NCT02514928
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-08-02
• Study First Submitted QC: 2015-08-03
• Study First Posted: 2015-08-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-10
• Last Update Posted: 2016-08-11
• Primary Completion: 2017-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 430

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pancreatoduodenectomy & nerve resection	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).
pancreatoduodenectomy	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

Name	Time	Method
Overall survival	2 years

Secondary Outcome Measures

Name	Time	Method
Pain Control	12 months	Pain control will be assess by the Visual Analogue Scale (VAS)

Trial Locations

Locations (1)

Pancreatic Cancer Institute; 🇨🇳 Shanghai, Shanghai, China