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

Not Applicable

• Conditions: Pancreatoduodenectomy
• Interventions: Procedure: 2D Laparoscopic pancreatoduodenectomy; Procedure: 3D Laparoscopic pancreatoduodenectomy

• Registration Number: NCT03754595
• Lead Sponsor: Peking Union Medical College Hospital

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.

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 Timeline

• Status Verified: 2018-11
• Study First Submitted: 2018-11-25
• Study First Submitted QC: 2018-11-26
• Last Update Submitted: 2018-11-26
• Study First Posted: 2018-11-27
• Last Update Posted: 2018-11-27
• Study Start: 2018-12-01
• Primary Completion: 2019-12-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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
2D Laparoscopic pancreatoduodenectomy	2D Laparoscopic pancreatoduodenectomy	Patients with pancreatic cancer treated by 2D Laparoscopic pancreatoduodenectomy
3D Laparoscopic pancreatoduodenectomy	3D Laparoscopic pancreatoduodenectomy	Patients with pancreatic cancer treated by 3D Laparoscopic pancreatoduodenectomy

Primary Outcome Measures

Name	Time	Method
Overall survival	60 month	overall survival duration after surgical treatment

Secondary 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