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OpenTrials
Completed

NCT Number: NCT02787187

Lymphadenectomy for Pancreatic Head Cancer: Standard or Extended?

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

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Key information

Conditions

Pancreatic Ductal Adenocarcinoma

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pancreaticoduodenectomy with Standard lymphadenectomy

Procedure

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

Pancreaticoduodenectomy with Extended lymphadenectomy

Procedure

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

Primary outcomes

  1. All-cause mortality

    Time frame: 3yrs post-operation

Secondary outcomes

  1. all-cause mortality

    Time frame: 1yr post-operation

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

  • Shanghai Zhongshan Hospital
  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Registry information

Official study title

A Prospective Randomized Controlled Study Comparing Standard and Extended Lymphadenectomy for Pancreatic Head Cancer

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jun 1, 2016
Registry last updated
Nov 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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