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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Surgery; Pancreatic Carcinoma

Treatments: Other: Open pancreaticoduodenectomy; Procedure: Minimally-invasive pancreaticoduodenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03747588

Pumch06342

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

Minimally-invasive Pancreaticoduodenectomy

Experimental group

Description:

MIPD

Treatment:

Procedure: Minimally-invasive pancreaticoduodenectomy

Open Pancreaticoduodenectomy

Placebo Comparator group

Description:

OPD

Treatment:

Other: Open pancreaticoduodenectomy