Lymphadenectomy for Pancreatic Head Cancer: Standard or Extended?

NCT ID: NCT02787187

Last Updated: 2021-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2021-10-31

Brief Summary

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

Detailed Description

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Conditions

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Pancreatic Ductal Adenocarcinoma

Keywords

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Standard lymphadenectomy extended lymphadenectomy pancreaticoduodenectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Standard resection

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

Group Type ACTIVE_COMPARATOR

Pancreaticoduodenectomy with Standard lymphadenectomy

Intervention Type PROCEDURE

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

Extended resection

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

Group Type EXPERIMENTAL

Pancreaticoduodenectomy with Extended lymphadenectomy

Intervention Type PROCEDURE

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

Interventions

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Pancreaticoduodenectomy with Standard lymphadenectomy

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

Intervention Type PROCEDURE

Pancreaticoduodenectomy with Extended lymphadenectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Weishen WANG

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Baiyong SHEN

Role: STUDY_DIRECTOR

Shanghai Ruijin Pancreatic Disease Center

Locations

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Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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HBP-RCT-001

Identifier Type: -

Identifier Source: org_study_id