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

The Effect and Safety of Comparision Between Minimally-invasive and Open Pancreaticoduodenectomy for Pancreatic Cancer : A Randomized Prospective Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Pancreatic Carcinoma
• Intervention / Treatment: Procedure: Minimally-invasive pancreaticoduodenectomy; Other: Open pancreaticoduodenectomy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Menghua Dai, MD; Phone Number: +861069152600; Email: DaiMH@pumch.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
      • Contact: Dai Menghua

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Minimally-invasive Pancreaticoduodenectomy; MIPD	Procedure: Minimally-invasive pancreaticoduodenectomy; Minimally-invasive pancreaticoduodenectomy for resection of pancreatic tumor
Placebo Comparator: Open Pancreaticoduodenectomy; OPD	Other: Open pancreaticoduodenectomy; Open pancreaticoduodenectomy for resection of pancreatic tumor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall complications	The proportion of all complications after operation accounted for the total number of patients	Up to postoperative 30 days
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.	Up to postoperative 30 days
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.	Up to postoperative 30 days
Intra-abdominal infection	Positive cultures of collection of fluid or blood,or persistent fever necessitating treatment with antibiotics and positive detection in image test.	Up to postoperative 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay (day)	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks	Up to postoperative 2 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression-free survival	The period between the beginning of treatment and the observation of disease progression or the occurrence of death for any reason.	Up to postoperative 5 years

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 30, 2028

Study Registration Dates

• First Submitted: November 16, 2018
• First Submitted That Met QC Criteria: November 16, 2018
• First Posted (Actual): November 20, 2018

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: pancreatic cancer; minimally-invasive pancreaticoduodenectomy; open pancreaticoduodenectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: Pumch06342

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No