Comparative Study of Robotic, Laparoscopic and Open Surgery for Enucleation of Benign Pancreatic Neoplasms

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

COMPLETED

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-12-31

Brief Summary

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To determine the efficacy and safety of robotic, laparoscopic and open surgery for enucleation of benign pancreatic neuroendocrine tumors

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Detailed Description

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The study was prospective and retrospective, non-randomized study included patients with benign pancreatic neoplasms. The robotic arm consecutively includes patients underwent robotic enucleation surgery and expected number in this arm is 50. The laparoscopic and open surgery arms retrospectively include case from the year 2004. The number of patients for laparoscopic and open surgery arms are 50 and 100, respectively.

Conditions

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Pancreatic Neuroendocrine Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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robotic arm

robotic surgery for enucleation benign Pancreatic Neuroendocrine Tumors Case number = 50

Group Type EXPERIMENTAL

Robotic surgery

Intervention Type PROCEDURE

Robotic surgery: enucleation benign Pancreatic Neuroendocrine Tumors

Laparoscopic surgery

laparoscopic surgery for enucleation benign Pancreatic Neuroendocrine Tumors Case number = 50

Group Type EXPERIMENTAL

Laparoscopic surgery

Intervention Type PROCEDURE

Laparoscopic surgery: enucleation benign Pancreatic Neuroendocrine Tumors

Open surgery

Open surgery for enucleation benign Pancreatic Neuroendocrine Tumors Case number = 100

Group Type EXPERIMENTAL

Open surgery

Intervention Type PROCEDURE

Open surgery: enucleation benign Pancreatic Neuroendocrine Tumors

Interventions

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Robotic surgery

Robotic surgery: enucleation benign Pancreatic Neuroendocrine Tumors

Intervention Type PROCEDURE

Laparoscopic surgery

Laparoscopic surgery: enucleation benign Pancreatic Neuroendocrine Tumors

Intervention Type PROCEDURE

Open surgery

Open surgery: enucleation benign Pancreatic Neuroendocrine Tumors

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 18-80 years old
* Body Mass Index\<30
* Preoperative diagnosis of resectable benign Pancreatic Neuroendocrine Tumors
* Tumor type: Non-functional pancreatic endocrine tumours and insulinomas
* largest diameter \< 4cm
* Preoperative CT showed no evidence that tumor was connected with main pancreatic duct

Exclusion Criteria

* Severe cardio/pulmonary complications
* Other pancreatic diseases, including pancreatitis and pancreatic cancer
* Multiple pancreatic neuroendocrine tumors
* Distant metastasis

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No