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Should a Standard Lymphadenectomy Include the No. 16 Lymph Nodes for Patients With Pancreatic Head Adenocarcinoma.

Primary Purpose

Pancreatic Ductal Adenocarcinoma

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Extended Lymphadenectomy
Standard 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 RCT, Standard lymphadenectomy, Extended lymphadenectomy, Pancreaticoduodenectomy

Eligibility Criteria

18 Years - 70 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 lymphadenectomy

Extended lymphadenectomy

Arm Description

Standard lymphadenectomy includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b lymph nodes harvested during the pancreaticoduodenectomy with CHILD's digestive reconstruction

In addition to the standard lymphadenectomy, para-aortic lymph nodes (No16) is included, in particular No 16b1 lymph nodes (Lymph nodes along the psterior side of the pancreas between the aorta and inferior vena cava).

Outcomes

Primary Outcome Measures

1 year overall survival rate
1 year overall survival rate
3 years overall survival rate
3 years overall survival rate
5 years overall survival rate
5 years overall survival rate

Secondary Outcome Measures

Postoperative Complications
pancreatic fistula, bile leakage, haemorrhage, DGE, etc
1, 3 & 5 years disease free survival rate
1, 3 & 5 years disease free survival rate

Full Information

First Posted
October 2, 2019
Last Updated
October 16, 2023
Sponsor
Ruijin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04115527
Brief Title
Should a Standard Lymphadenectomy Include the No. 16 Lymph Nodes for Patients With Pancreatic Head Adenocarcinoma.
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
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of this study is to determine whether para-aortic lymph nodes(No.16) should be included in the lymphadenectomy during the pancreatoduodenectomy in order to improve the long-term survival of patients with pancreatic head ductal adenocarcinoma.
Detailed Description
Pancreatic cancer is now raised to the 7th leading cause of death. Surgical resection seems to be the unique curative therapy for pancreatic cancer. The pancreaticoduodenectomy is widely performed for the patients with pancreatic head cancer in recent decades. The lymphadenectomy is an indispensible procedure. In 2014, the International Study Group for Pancreatic Surgery (ISGPS) recommended a standard lymphadenectomy should include lymph node stations 5, 6, 8a, 12b1, 12b2, 12c, 13a, 13b, 14a, 14b, 17a, and 17b. However, no consensus was reached on Lymph node 16 in particular 16b1. There was no stronge evidence available concerning the impact on survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Ductal Adenocarcinoma
Keywords
RCT, 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
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard lymphadenectomy
Arm Type
Active Comparator
Arm Description
Standard lymphadenectomy includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b lymph nodes harvested during the pancreaticoduodenectomy with CHILD's digestive reconstruction
Arm Title
Extended lymphadenectomy
Arm Type
Experimental
Arm Description
In addition to the standard lymphadenectomy, para-aortic lymph nodes (No16) is included, in particular No 16b1 lymph nodes (Lymph nodes along the psterior side of the pancreas between the aorta and inferior vena cava).
Intervention Type
Procedure
Intervention Name(s)
Extended Lymphadenectomy
Intervention Description
Lymph node dissection includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 16 17a 17b lymph nodes
Intervention Type
Procedure
Intervention Name(s)
Standard Lymphadenectomy
Intervention Description
Lymph node dissection includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b lymph nodes
Primary Outcome Measure Information:
Title
1 year overall survival rate
Description
1 year overall survival rate
Time Frame
1 year post-operation
Title
3 years overall survival rate
Description
3 years overall survival rate
Time Frame
3 years post-operation
Title
5 years overall survival rate
Description
5 years overall survival rate
Time Frame
5 years post-operation
Secondary Outcome Measure Information:
Title
Postoperative Complications
Description
pancreatic fistula, bile leakage, haemorrhage, DGE, etc
Time Frame
Within 90 days or before discharge
Title
1, 3 & 5 years disease free survival rate
Description
1, 3 & 5 years disease free survival rate
Time Frame
1, 3 & 5 years post-operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 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
Jiancheng WANG, Dr
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
200025
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Should a Standard Lymphadenectomy Include the No. 16 Lymph Nodes for Patients With Pancreatic Head Adenocarcinoma.

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