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

NCT03754595 | Unknown

• 1 other identifier: DaiMH
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreatoduodenectomy

Keywords

2D and 3D Laparoscopic pancreatoduodenectomy

Outcome Measures

Primary Outcomes (1)

• Overall survival

  overall survival duration after surgical treatment

  60 month

Secondary Outcomes (1)

• Overall complications

  Up to postoperative 30 days

Other Outcomes (2)

• Operative time

  12 hours

• Pancreatic fistula

  Up to postoperative 30 days

Study Arms (2)

2D Laparoscopic pancreatoduodenectomy

ACTIVE COMPARATOR

Patients with pancreatic cancer treated by 2D Laparoscopic pancreatoduodenectomy

Procedure: 2D Laparoscopic pancreatoduodenectomy

3D Laparoscopic pancreatoduodenectomy

EXPERIMENTAL

Patients with pancreatic cancer treated by 3D Laparoscopic pancreatoduodenectomy

Procedure: 3D Laparoscopic pancreatoduodenectomy

Interventions

3D Laparoscopic pancreatoduodenectomy PROCEDURE

Patients with pancreatic cancer treated by 3D Laparoscopic pancreatoduodenectomy

3D Laparoscopic pancreatoduodenectomy

2D Laparoscopic pancreatoduodenectomy PROCEDURE

2D Laparoscopic pancreatoduodenectomy

2D Laparoscopic pancreatoduodenectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Officials

• Menghua Dai, MD

  Peking Union Medical Coll3ge hospital

  STUDY DIRECTOR

Central Study Contacts

Cheng Ding, MD

CONTACT

+861069152601; dingcheng13@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two parallel groups: 2DLaparoscopic pancreatoduodenectomy and 3DLaparoscopic pancreatoduodenectomy

Study Record Dates

• First Submitted: November 25, 2018
• First Posted: November 27, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2021
• Last Updated: November 27, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share