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

Primary Purpose

Pancreatic Carcinoma, Surgery

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Minimally-invasive pancreaticoduodenectomy
Open pancreaticoduodenectomy
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Carcinoma focused on measuring minimally-invasive pancreaticoduodenectomy, open pancreaticoduodenectomy, pancreatic cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chinese Academy of Medical Sciences & Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Minimally-invasive Pancreaticoduodenectomy

Open Pancreaticoduodenectomy

Arm Description

MIPD

OPD

Outcomes

Primary Outcome Measures

Overall complications
The proportion of all complications after operation accounted for the total number of patients
Pancreatic fistula
The international study group (ISGPF) definition: A drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity. Three different grades of postoperative fistula (grades A, B, C) are defined according to the clinical impact on the patient's hospital course.
Intra-abdominal bleeding
The International Study Group of Pancreatic Surgery (ISGPS) definition: Blood loss through abdominal drains or nasogastric tube;hematemesis or melena; clinical deterioration of the patient; unexplained hypotension or tachycardia; or laboratory findings such as a decreasing hemoglobin concentration.
Intra-abdominal infection
Positive cultures of collection of fluid or blood,or persistent fever necessitating treatment with antibiotics and positive detection in image test.

Secondary Outcome Measures

Length of hospital stay (day)
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Full Information

First Posted
November 16, 2018
Last Updated
September 30, 2022
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03747588
Brief Title
The Comparision of Minimally-invasive and Open Pancreaticoduodenectomy for Pancreatic Cancer
Acronym
MIOPP
Official Title
The Effect and Safety of Comparision Between Minimally-invasive and Open Pancreaticoduodenectomy for Pancreatic Cancer : A Randomized Prospective Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Carcinoma, Surgery
Keywords
minimally-invasive pancreaticoduodenectomy, open pancreaticoduodenectomy, pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Minimally-invasive Pancreaticoduodenectomy
Arm Type
Experimental
Arm Description
MIPD
Arm Title
Open Pancreaticoduodenectomy
Arm Type
Placebo Comparator
Arm Description
OPD
Intervention Type
Procedure
Intervention Name(s)
Minimally-invasive pancreaticoduodenectomy
Intervention Description
Minimally-invasive pancreaticoduodenectomy for resection of pancreatic tumor
Intervention Type
Other
Intervention Name(s)
Open pancreaticoduodenectomy
Intervention Description
Open pancreaticoduodenectomy for resection of pancreatic tumor
Primary Outcome Measure Information:
Title
Overall complications
Description
The proportion of all complications after operation accounted for the total number of patients
Time Frame
Up to postoperative 30 days
Title
Pancreatic fistula
Description
The international study group (ISGPF) definition: A drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity. Three different grades of postoperative fistula (grades A, B, C) are defined according to the clinical impact on the patient's hospital course.
Time Frame
Up to postoperative 30 days
Title
Intra-abdominal bleeding
Description
The International Study Group of Pancreatic Surgery (ISGPS) definition: Blood loss through abdominal drains or nasogastric tube;hematemesis or melena; clinical deterioration of the patient; unexplained hypotension or tachycardia; or laboratory findings such as a decreasing hemoglobin concentration.
Time Frame
Up to postoperative 30 days
Title
Intra-abdominal infection
Description
Positive cultures of collection of fluid or blood,or persistent fever necessitating treatment with antibiotics and positive detection in image test.
Time Frame
Up to postoperative 30 days
Secondary Outcome Measure Information:
Title
Length of hospital stay (day)
Description
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Time Frame
Up to postoperative 2 weeks
Other Pre-specified Outcome Measures:
Title
progression-free survival
Description
The period between the beginning of treatment and the observation of disease progression or the occurrence of death for any reason.
Time Frame
Up to postoperative 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Menghua Dai, MD
Phone
+861069152600
Email
DaiMH@pumch.cn
Facility Information:
Facility Name
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dai Menghua

12. IPD Sharing Statement

Learn more about this trial

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

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