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

Pancreatoduodenectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03754595
• Other study ID #: DaiMH
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 1, 2021

Study information

• Verified date: November 2018
• Source: Peking Union Medical College Hospital
• Contact: Cheng Ding, MD
• Phone: +861069152601
• Email: dingcheng13[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatoduodenectomy

Intervention

Procedure:
• 3D Laparoscopic pancreatoduodenectomy
Patients with pancreatic cancer treated by 3D Laparoscopic pancreatoduodenectomy
• 2D Laparoscopic pancreatoduodenectomy
2D Laparoscopic pancreatoduodenectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Operative time	Durtion of operation	12 hours
Other	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
Primary	Overall survival	overall survival duration after surgical treatment	60 month
Secondary	Overall complications	The proportion of all complications after operation accounted for the total number of patients	Up to postoperative 30 days