Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Lymphadenectomy for Pancreatic Head Cancer: Standard or Extended?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02787187
Recruitment Status : Active, not recruiting
First Posted : June 1, 2016
Last Update Posted : March 31, 2020
Sponsor:
Collaborators:
Shanghai Zhongshan Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
Weishen WANG, Ruijin Hospital

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

Condition or disease Intervention/treatment Phase
Pancreatic Ductal Adenocarcinoma Procedure: Pancreaticoduodenectomy with Standard lymphadenectomy Procedure: Pancreaticoduodenectomy with Extended lymphadenectomy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Study Comparing Standard and Extended Lymphadenectomy for Pancreatic Head Cancer
Actual Study Start Date : July 1, 2016
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : December 2021

Arm Intervention/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 Measures :
  1. All-cause mortality [ Time Frame: 3yrs post-operation ]

Secondary Outcome Measures :
  1. all-cause mortality [ Time Frame: 1yr post-operation ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787187


Locations
Layout table for location information
China, Shanghai
Shanghai Ruijin Hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Ruijin Hospital
Shanghai Zhongshan Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
Layout table for investigator information
Study Director: Baiyong SHEN Shanghai Ruijin Pancreatic Disease Center
Layout table for additonal information
Responsible Party: Weishen WANG, Doctor, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT02787187    
Other Study ID Numbers: HBP-RCT-001
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Weishen WANG, Ruijin Hospital:
Standard lymphadenectomy
extended lymphadenectomy
pancreaticoduodenectomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site