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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2021-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pancreatoduodenectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two parallel groups: 2DLaparoscopic pancreatoduodenectomy and 3DLaparoscopic pancreatoduodenectomy

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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2D Laparoscopic pancreatoduodenectomy

Patients with pancreatic cancer treated by 2D Laparoscopic pancreatoduodenectomy

Group Type ACTIVE_COMPARATOR

2D Laparoscopic pancreatoduodenectomy

Intervention Type PROCEDURE

2D Laparoscopic pancreatoduodenectomy

3D Laparoscopic pancreatoduodenectomy

Patients with pancreatic cancer treated by 3D Laparoscopic pancreatoduodenectomy

Group Type EXPERIMENTAL

3D Laparoscopic pancreatoduodenectomy

Intervention Type PROCEDURE

Patients with pancreatic cancer treated by 3D Laparoscopic pancreatoduodenectomy

Interventions

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3D Laparoscopic pancreatoduodenectomy

Patients with pancreatic cancer treated by 3D Laparoscopic pancreatoduodenectomy

Intervention Type PROCEDURE

2D Laparoscopic pancreatoduodenectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No