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

Surgery Clinical Trial

— MIOPP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03747588
• Other study ID #: Pumch06342
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 30, 2028

Study information

• Verified date: September 2022
• Source: Peking Union Medical College Hospital
• Contact: Menghua Dai, MD
• Phone: +861069152600
• Email: DaiMH[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2028
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Carcinoma
• Pancreatic Neoplasms
• Surgery

Intervention

Procedure:
• Minimally-invasive pancreaticoduodenectomy
Minimally-invasive pancreaticoduodenectomy for resection of pancreatic tumor

Other:
• Open pancreaticoduodenectomy
Open pancreaticoduodenectomy for resection of pancreatic tumor

Locations

Country	Name	City	State
China	Chinese Academy of Medical Sciences & Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Overall complications	The proportion of all complications after operation accounted for the total number of patients	Up to postoperative 30 days
Primary	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
Primary	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
Primary	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	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