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

Pancreatic Neuroendocrine Tumors Clinical Trial

Official title:

Comparative Study of the Efficacy and Safety Outcomes of Robotic, Laparoscopic and Open Surgery for Enucleation of Benign Pancreatic Neuroendocrine Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02125929
• Other study ID #: PUMCHGS2013
• Secondary ID: ENRLO
• Status: Completed
• Phase: N/A
• First received: April 26, 2014
• Last updated: August 4, 2015
• Start date: April 2014
• Est. completion date: December 2014

Study information

• Verified date: August 2015
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoid Tumor
• Neuroendocrine Tumors
• Pancreatic Neuroendocrine Tumors

Intervention

Procedure:
• Robotic surgery
Robotic surgery: enucleation benign Pancreatic Neuroendocrine Tumors
• Laparoscopic surgery
Laparoscopic surgery: enucleation benign Pancreatic Neuroendocrine Tumors
• Open surgery
Open surgery: enucleation benign Pancreatic Neuroendocrine Tumors

Locations

Country	Name	City	State
China	Department of General Surgery, Peking Union medical school hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intra-operative bleeding volume		intra operative	Yes
Other	Operation Time		Intra operative	No
Other	Conversion rate to open surgery	Only applied to the robotic surgery arm and laparoscopic arm	Intra operative	No
Other	Quality of life and pain scores		up to 30 days	No
Other	Delayed gastric emptying rate		up to 30 days	Yes
Other	Intra-abdominal bleeding rate		up to 30 days	Yes
Other	Postoperative infection rate		up to 30 days	Yes
Other	Hospital stay time		up to 30 days	No
Primary	Pancreatic fistula rate		up to 30 days	Yes
Secondary	Mortality rate		up to 30 days	Yes