The Comparision of Minimally-invasive and Open Pancreaticoduodenectomy for Pancreatic Cancer

NCT ID: NCT03747588

Last Updated: 2022-10-03

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

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2028-12-30

Brief Summary

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Minimally invasive pancreaticoduodenectomy remains one of the most challenging abdominal procedures. Safety and feasibility remain controversial when comparing minimally-invasive with open pancreaticoduodenectomy, especially for malignant tumors.The aim of this study was to compare minimally invasive and open pancreatoduodenectomy for short-term outcomes and long-term follow-up in a randomized trial.

Detailed Description

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This study is to compare the efficiency and safety between minimally invasive (including laparoscopic and robotic) and open pancreaticoduodenectomy for pancreatic cancer. We design a prospective randomized study. Patients with malignant pancreatic tumor who underwent pancreatoduodenectomy are recruited to the study. After obtaining informed consent, eligible patients are randomly allocated to minimally-invasive or open group before the operation day. The outcomes evaluated were hospital stay, and blood loss, radicality of surgery, duration of operation and complication rate as well as disease free survival and overall survival.

Conditions

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Pancreatic Carcinoma Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Minimally-invasive Pancreaticoduodenectomy

MIPD

Group Type EXPERIMENTAL

Minimally-invasive pancreaticoduodenectomy

Intervention Type PROCEDURE

Minimally-invasive pancreaticoduodenectomy for resection of pancreatic tumor

Open Pancreaticoduodenectomy

OPD

Group Type PLACEBO_COMPARATOR

Open pancreaticoduodenectomy

Intervention Type OTHER

Open pancreaticoduodenectomy for resection of pancreatic tumor

Interventions

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Minimally-invasive pancreaticoduodenectomy

Minimally-invasive pancreaticoduodenectomy for resection of pancreatic tumor

Intervention Type PROCEDURE

Open pancreaticoduodenectomy

Open pancreaticoduodenectomy for resection of pancreatic tumor

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age: \>18yr, \<75yr
* Patients with pancreatic cancer or non-pancreatic cancers (biliary duct cancer or ampullary cancer) who underwent pancreatoduodenectomy
* Preoperative imaging assessment is resectable or borderline resectable

Exclusion Criteria

* Benign tumors of the head of pancreas
* Enhanced CT diagnosis revealed that the excess of SMV was more than 180 degrees, or distant metastasis.
* conversion to laparotomy because of intraoperative difficulty
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chinese Academy of Medical Sciences & Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Menghua Dai, MD

Role: CONTACT

+861069152600

Facility Contacts

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Dai Menghua

Role: primary

Other Identifiers

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Pumch06342

Identifier Type: -

Identifier Source: org_study_id

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