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Lymphadenectomy for Pancreatic Head Cancer: Standard or Extended?


2016-07-01


2021-10


2021-10


230

Study Overview

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

N/A

  • Pancreatic Ductal Adenocarcinoma
  • PROCEDURE: Pancreaticoduodenectomy with Standard lymphadenectomy
  • PROCEDURE: Pancreaticoduodenectomy with Extended lymphadenectomy
  • HBP-RCT-001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2016-05-23  

N/A  

2021-11-22  

2016-05-25  

N/A  

2021-11-23  

2016-06-01  

N/A  

2021-11  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment


Allocation:
Randomized


Interventional Model:
Parallel


Masking:
Quadruple


Arms and Interventions

Participant Group/ArmIntervention/Treatment
ACTIVE_COMPARATOR: Standard resection

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

PROCEDURE: Pancreaticoduodenectomy with Standard lymphadenectomy

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

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

PROCEDURE: Pancreaticoduodenectomy with Extended lymphadenectomy

  • Pancreaticoduodenectomy:child's digestive reconstruction extended lymphadenectomy: No8p 12a 12p 14c 14d 16
Primary Outcome MeasuresMeasure DescriptionTime Frame
All-cause mortality3yrs post-operation
Secondary Outcome MeasuresMeasure DescriptionTime Frame
all-cause mortality1yr post-operation

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

  • STUDY_DIRECTOR: Baiyong SHEN, Shanghai Ruijin Pancreatic Disease Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available