NCT04115527

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2019

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

5.6 years

First QC Date

October 2, 2019

Last Update Submit

October 16, 2023

Conditions

Pancreatic Ductal Adenocarcinoma

Keywords

RCTStandard lymphadenectomyExtended lymphadenectomyPancreaticoduodenectomy

Outcome Measures

Primary Outcomes (3)

  • 1 year overall survival rate

    1 year overall survival rate

    1 year post-operation

  • 3 years overall survival rate

    3 years overall survival rate

    3 years post-operation

  • 5 years overall survival rate

    5 years overall survival rate

    5 years post-operation

Secondary Outcomes (2)

  • Postoperative Complications

    Within 90 days or before discharge

  • 1, 3 & 5 years disease free survival rate

    1, 3 & 5 years post-operation

Study Arms (2)

Standard lymphadenectomy

ACTIVE COMPARATOR

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

Procedure: Standard Lymphadenectomy

Extended lymphadenectomy

EXPERIMENTAL

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).

Procedure: Extended Lymphadenectomy

Interventions

Extended LymphadenectomyPROCEDURE

Lymph node dissection includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 16 17a 17b lymph nodes

Extended lymphadenectomy
Standard LymphadenectomyPROCEDURE

Lymph node dissection includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b lymph nodes

Standard lymphadenectomy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologic diagnosis of pancreatic ductal adenocarcinoma
  • Signed the informed consents

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

Study Officials

  • Jiancheng WANG, Dr

    Shanghai Ruijin Pancreatic Disease Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 2, 2019

First Posted

October 4, 2019

Study Start

June 1, 2018

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

October 17, 2023

Record last verified: 2023-10

Locations

CN(1)