Application of 2D and 3D Laparoscopy in Laparoscopic Pancreaticoduodenectomy: a Prospective Randomized Clinical Trial

Pancreatic cancer is extremely malignant, with a low sensibility to chemotherapy and radiotherapy, and a poor prognosis. Surgical treatment is very important for pancreatic cancer. Laparoscopic pancreatoduodenectomy is a standard radical procedure we are going to compare and discuss the advantages of 2D and 3D Laparoscopic pancreatoduodenectomy in our RCT study.

Study Overview

• Status: Unknown
• Conditions: Pancreatoduodenectomy
• Intervention / Treatment: Procedure: 2D Laparoscopic pancreatoduodenectomy; Procedure: 3D Laparoscopic pancreatoduodenectomy

Detailed Description

This study is to compare the efficiency and safety between 2D laparoscopic pancreatoduodenectomy and 2D laparoscopic 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 2D laparoscopic or 3D laparoscopic group before the operation day . The outcomes evaluated were hospital stay, and blood loss, radicality of surgery, duration of operation and complication rate.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

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
Active Comparator: 2D Laparoscopic pancreatoduodenectomy; Patients with pancreatic cancer treated by 2D Laparoscopic pancreatoduodenectomy	Procedure: 2D Laparoscopic pancreatoduodenectomy; 2D Laparoscopic pancreatoduodenectomy
Experimental: 3D Laparoscopic pancreatoduodenectomy; Patients with pancreatic cancer treated by 3D Laparoscopic pancreatoduodenectomy	Procedure: 3D Laparoscopic pancreatoduodenectomy; Patients with pancreatic cancer treated by 3D Laparoscopic pancreatoduodenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	overall survival duration after surgical treatment	60 month

Secondary 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Operative time	Durtion of operation	12 hours

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Director: Menghua Dai, MD, Peking Union Medical Coll3ge hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: November 25, 2018
• First Submitted That Met QC Criteria: November 26, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Actual): November 27, 2018
• Last Update Submitted That Met QC Criteria: November 26, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: 2D and 3D Laparoscopic pancreatoduodenectomy
• Other Study ID Numbers: DaiMH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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