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

Not Applicable

Recruiting

• Conditions: Pancreatic Carcinoma; Surgery
• Interventions: Procedure: Minimally-invasive pancreaticoduodenectomy; Other: Open pancreaticoduodenectomy

• Registration Number: NCT03747588
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Study First Submitted: 2018-11-16
• Study First Submitted QC: 2018-11-16
• Study First Posted: 2018-11-20
• Study Start: 2018-12-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-30
• Last Update Posted: 2022-10-03
• Primary Completion: 2023-12-01
• Study Completion: 2028-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Minimally-invasive Pancreaticoduodenectomy	Minimally-invasive pancreaticoduodenectomy	MIPD
Open Pancreaticoduodenectomy	Open pancreaticoduodenectomy	OPD

Primary Outcome Measures

Name	Time	Method
Overall complications	Up to postoperative 30 days	The proportion of all complications after operation accounted for the total number of patients
Intra-abdominal infection	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.
Pancreatic fistula	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.
Intra-abdominal bleeding	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chinese Academy of Medical Sciences & Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China