Clinical Study Between Robotic and Open Surgery in Patients With Pancreatic Cancer

NCT ID: NCT04211948

Last Updated: 2021-04-09

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2024-12-31

Brief Summary

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The purpose of this study is to determine whether robotic surgery has limitations in terms of patient age, tumor size, location, and vascular relationship when compared to open surgery for pancreatic cancer. Whether robotic surgery has advantages over intraoperative bleeding, operative time, postoperative complications (bleeding, infection, pancreatic fistula) and postoperative hospital stays compared to open surgery.And the differences in lymph nodes harvest and postoperative survival between two groups.

Detailed Description

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Conditions

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Pancreatic Ductal Adenocarcinoma Minimally Invasive Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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robotic pancreatectomy

robotic pancreatectomy(including pancreaticoduodenectomy and distal pancreatectomy)

Group Type EXPERIMENTAL

robotic surgery

Intervention Type PROCEDURE

Pancreatectomy with robotic assisted system

open surgery

open pancreatectomy(including pancreaticoduodenectomy and distal pancreatectomy)

Group Type ACTIVE_COMPARATOR

open surgery

Intervention Type PROCEDURE

Traditional open pancreatectomy

Interventions

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robotic surgery

Pancreatectomy with robotic assisted system

Intervention Type PROCEDURE

open surgery

Traditional open pancreatectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Diagnosed pancreatic ductal adenocarcinoma
* Patients and their families volunteered to test and signed informed consent.

Exclusion Criteria

* Preoperative exclusion:

1. Patients with metastasis (M1)
2. Patients with tumor recurrence
3. Patients with artery and/or vein invasion and can't perform radical resection and reconstruction
4. Patients with poor cardiopulmonary function cannot tolerate surgery;
5. receive neoadjuvant radiotherapy and chemotherapy before surgery;
6. The patient or family member refuses to join the group;
7. Pregnant patients
* Intraoperative exclusion:

1. Intraoperative exploration of metastases in other parts besides the primary lesion
2. Other organs malignant tumors metastasize to the pancreas
* Postoperative exclusion:

1. pathology confirmed non-pancreatic ductal adenocarcinoma
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kai Qin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kai Qin

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

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Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kai Qin, Doctor

Role: CONTACT

0086-(0)21-64370045 ext. 670902

Facility Contacts

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Kai Qin

Role: primary

0086-(0)21-64370045 ext. +8613671917328

Other Identifiers

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HBP-RWR-001

Identifier Type: -

Identifier Source: org_study_id

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