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Lymphadenectomy for Pancreatic Head Cancer: Standard or Extended?

Primary Purpose

Pancreatic Ductal Adenocarcinoma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pancreaticoduodenectomy with Standard lymphadenectomy
Pancreaticoduodenectomy with Extended lymphadenectomy
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Ductal Adenocarcinoma focused on measuring Standard lymphadenectomy, extended lymphadenectomy, pancreaticoduodenectomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Shanghai Ruijin Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard resection

Extended resection

Arm Description

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

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

Outcomes

Primary Outcome Measures

All-cause mortality

Secondary Outcome Measures

all-cause mortality

Full Information

First Posted
May 23, 2016
Last Updated
November 22, 2021
Sponsor
Ruijin Hospital
Collaborators
Shanghai Zhongshan Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02787187
Brief Title
Lymphadenectomy for Pancreatic Head Cancer: Standard or Extended?
Official Title
A Prospective Randomized Controlled Study Comparing Standard and Extended Lymphadenectomy for Pancreatic Head Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
October 2021 (Actual)
Study Completion Date
October 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
Collaborators
Shanghai Zhongshan Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Ductal Adenocarcinoma
Keywords
Standard lymphadenectomy, extended lymphadenectomy, pancreaticoduodenectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard resection
Arm Type
Active Comparator
Arm Description
Pancreaticoduodenectomy (child's digestive reconstruction); Standard lymphadenectomy: No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b
Arm Title
Extended resection
Arm Type
Experimental
Arm Description
Pancreaticoduodenectomy (child's digestive reconstruction)extended lymphadenectomy No8p 12a 12p 14c 14d 16
Intervention Type
Procedure
Intervention Name(s)
Pancreaticoduodenectomy with Standard lymphadenectomy
Intervention Description
Pancreaticoduodenectomy：child's digestive reconstruction standard lymphadenectomy: No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b
Intervention Type
Procedure
Intervention Name(s)
Pancreaticoduodenectomy with Extended lymphadenectomy
Intervention Description
Pancreaticoduodenectomy：child's digestive reconstruction extended lymphadenectomy: No8p 12a 12p 14c 14d 16
Primary Outcome Measure Information:
Title
All-cause mortality
Time Frame
3yrs post-operation
Secondary Outcome Measure Information:
Title
all-cause mortality
Time Frame
1yr post-operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baiyong SHEN
Organizational Affiliation
Shanghai Ruijin Pancreatic Disease Center
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Lymphadenectomy for Pancreatic Head Cancer: Standard or Extended?

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