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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Completed

Conditions: Pancreatic Neuroendocrine Tumors

Treatments: Procedure: Open surgery; Procedure: Robotic surgery; Procedure: Laparoscopic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02125929

PUMCHGS2013

ENRLO (Other Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 156 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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156 participants in 3 patient groups

robotic arm

Experimental group

Description:

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

Treatment:

Procedure: Robotic surgery

Laparoscopic surgery

Experimental group

Description:

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

Treatment:

Procedure: Laparoscopic surgery

Open surgery

Experimental group

Description:

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

Treatment:

Procedure: Open surgery