Comparing Laparoscopic and Open Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas

NCT ID: NCT05788029

Last Updated: 2025-08-11

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

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2028-12-31

Brief Summary

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The aim of this study was to evaluate the outcomes of LPD versus OPD in non-pancreatic periampullary adenocarcinoma

Detailed Description

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The aim of this study was to evaluate the outcomes of LPD versus OPD in non-pancreatic periampullary adenocarcinoma

Conditions

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Periampullary Adenocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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laparoscopic pancreaticoduodenectomy

laparoscopic pancreaticoduodenectomy

Group Type EXPERIMENTAL

laparoscopic pancreaticoduodenectomy

Intervention Type PROCEDURE

laparoscopic pancreaticoduodenectomy

open pancreaticoduodenectomy

open pancreaticoduodenectomy

Group Type ACTIVE_COMPARATOR

open pancreaticoduodenectomy

Intervention Type PROCEDURE

open pancreaticoduodenectomy

Interventions

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laparoscopic pancreaticoduodenectomy

laparoscopic pancreaticoduodenectomy

Intervention Type PROCEDURE

open pancreaticoduodenectomy

open pancreaticoduodenectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Age between 18 years and 75 years.
2. Histologically confirmed NPPC or clinically diagnosed NPPC by an MDT without histopathologic evidence.
3. Patients feasible to undergo both LPD and OPD ac- cording to MDT evaluations.
4. Patients understanding and willing to comply with this trial.
5. Provision of written informed consent before patient registration.
6. Patients meeting the curative treatment intent in ac- cordance with clinical guidelines.

Exclusion Criteria

1. Patients with distant metastases, including peritone- al, liver, distant lymph node metastases and involve- ment of other organs.
2. Patients requiring left, central or total pancreatecto- my or other palliative surgery.
3. Preoperative American Society of Anaesthesiologists (ASA) score ≥4.
4. History of other malignant disease
5. Pregnant or breastfeeding women.
6. Patients with serious mental disorders
7. Patients treated with neoadjuvant therapy.
8. Patients with vascular invasion and requiring vascular resection as evaluated by the MDT team according to abdominal imaging data.
9. Body mass index \>35 kg/m 2 .
10. Patients participating in any other clinical trials with- in 3 months.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Xuzhou Medical University

OTHER

Sponsor Role collaborator

The Third Affiliated Hospital of Soochow University

OTHER

Sponsor Role collaborator

Shanxi Province Cancer Hospital

OTHER

Sponsor Role collaborator

Army Medical University, China

OTHER

Sponsor Role collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of University of South China

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

Chongqing General Hospital

OTHER

Sponsor Role collaborator

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role collaborator

Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Renyi Qin

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Renyi Qin

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

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Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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TJDBPS14

Identifier Type: OTHER

Identifier Source: secondary_id

TJDBPS14

Identifier Type: -

Identifier Source: org_study_id

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