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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Pancreatoduodenectomy

Treatments: Procedure: 2D Laparoscopic pancreatoduodenectomy; Procedure: 3D Laparoscopic pancreatoduodenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03754595

DaiMH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

2D Laparoscopic pancreatoduodenectomy

Active Comparator group

Description:

Patients with pancreatic cancer treated by 2D Laparoscopic pancreatoduodenectomy

Treatment:

Procedure: 2D Laparoscopic pancreatoduodenectomy

3D Laparoscopic pancreatoduodenectomy

Experimental group

Description:

Patients with pancreatic cancer treated by 3D Laparoscopic pancreatoduodenectomy

Treatment:

Procedure: 3D Laparoscopic pancreatoduodenectomy