Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03747588

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Pancreatic Carcinoma Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Surgery

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese Academy of Medical Sciences & Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location status: Recruiting

Location contact

Dai Menghua

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Minimally-invasive pancreaticoduodenectomy

Procedure

Minimally-invasive pancreaticoduodenectomy for resection of pancreatic tumor

Open pancreaticoduodenectomy

Other

Open pancreaticoduodenectomy for resection of pancreatic tumor

Primary outcomes

  1. Overall complications

    Time frame: Up to postoperative 30 days

    The proportion of all complications after operation accounted for the total number of patients

  2. Pancreatic fistula

    Time frame: Up to postoperative 30 days

    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.

  3. Intra-abdominal bleeding

    Time frame: Up to postoperative 30 days

    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.

  4. Intra-abdominal infection

    Time frame: Up to postoperative 30 days

    Positive cultures of collection of fluid or blood,or persistent fever necessitating treatment with antibiotics and positive detection in image test.

Secondary outcomes

  1. Length of hospital stay (day)

    Time frame: Up to postoperative 2 weeks

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

Other outcomes

  1. progression-free survival

    Time frame: Up to postoperative 5 years

    The period between the beginning of treatment and the observation of disease progression or the occurrence of death for any reason.

Study contacts

Contact information is provided by the study sponsor or research team.

Menghua Dai, MD

CONTACT

[email protected]

+861069152600

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Acronym: MIOPP

Important dates

Study start
2018
Primary completion
2023
Study completion
2028
First posted
Nov 20, 2018
Registry last updated
Oct 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.