NCT02787187

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 23, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

5.3 years

First QC Date

May 23, 2016

Last Update Submit

November 22, 2021

Conditions

Pancreatic Ductal Adenocarcinoma

Keywords

Standard lymphadenectomyextended lymphadenectomypancreaticoduodenectomy

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    3yrs post-operation

Secondary Outcomes (1)

  • all-cause mortality

    1yr post-operation

Study Arms (2)

Standard resection

ACTIVE COMPARATOR

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

Extended resection

EXPERIMENTAL

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

Procedure: Pancreaticoduodenectomy with Extended lymphadenectomy

Interventions

Pancreaticoduodenectomy with Standard lymphadenectomyPROCEDURE

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

Standard resection
Pancreaticoduodenectomy with Extended lymphadenectomyPROCEDURE

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

Extended resection

Eligibility Criteria

Age18 Years - 80 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, 200032, China

Location

MeSH Terms

Interventions

Pancreaticoduodenectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Baiyong SHEN

    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
Doctor

Study Record Dates

First Submitted

May 23, 2016

First Posted

June 1, 2016

Study Start

July 1, 2016

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

November 23, 2021

Record last verified: 2021-11

Locations

CN(1)