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

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03754595

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatoduodenectomy	Procedure: 3D Laparoscopic pancreatoduodenectomy Procedure: 2D Laparoscopic pancreatoduodenectomy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Two parallel groups: 2DLaparoscopic pancreatoduodenectomy and 3DLaparoscopic pancreatoduodenectomyTwo parallel groups: 2DLaparoscopic pancreatoduodenectomy and 3DLaparoscopic pancreatoduodenectomy

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2018

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Overall survival [60 month]
overall survival duration after surgical treatment

Secondary Outcome Measures

Overall complications [Up to postoperative 30 days]
The proportion of all complications after operation accounted for the total number of patients

Other Outcome Measures

Operative time [12 hours]
Durtion of operation
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Peking Union Medical College Hospital

Investigators

Study Director: Menghua Dai, MD, Peking Union Medical Coll3ge hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peking Union Medical College Hospital

ClinicalTrials.gov Identifier:

NCT03754595

Other Study ID Numbers:

DaiMH

First Posted:

Nov 27, 2018

Last Update Posted:

Nov 27, 2018

Last Verified:

Nov 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Peking Union Medical College Hospital

2D and 3D Laparoscopic pancreatoduodenectomy

Study Results

No Results Posted as of Nov 27, 2018