Lymphadenectomy for Pancreatic Head Cancer: Standard or Extended?

Shanghai Jiao Tong University

Status: Completed

Conditions: Pancreatic Ductal Adenocarcinoma

Treatments: Procedure: Pancreaticoduodenectomy with Standard lymphadenectomy; Procedure: Pancreaticoduodenectomy with Extended lymphadenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02787187

HBP-RCT-001

Details and patient eligibility

About

The purpose of this study is to compare outcomes of patients undergoing standard or extended lymphadenectomy in pancreaticoduodenectomy for pancreatic cancer

Enrollment: 230 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologic diagnosis of pancreatic ductal adenocarcinoma
• Signed the informed consents

Exclusion criteria

• Pathologic diagnosis of other pancreatic cancers
• Pre-operative anti-cancer treatment
• Recurrence patients
• Patients with contraindication(hepatic/ respiratory/ renal dysfunction, etc )
• Pre operative exam: Total bilirubin more than 250µmol/L
• AJCC stage IV
• Operation non radical

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

230 participants in 2 patient groups

Standard resection

Active Comparator group

Description:

Pancreaticoduodenectomy (child's digestive reconstruction); Standard lymphadenectomy: No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b

Treatment:

Procedure: Pancreaticoduodenectomy with Standard lymphadenectomy

Extended resection

Experimental group

Description:

Pancreaticoduodenectomy (child's digestive reconstruction)extended lymphadenectomy No8p 12a 12p 14c 14d 16

Treatment:

Procedure: Pancreaticoduodenectomy with Extended lymphadenectomy