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Lymphadenectomy for Pancreatic Head Cancer: Standard or Extended?

Shanghai Jiao Tong University logo

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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