NCT02125929

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 29, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 6, 2015

Status Verified

August 1, 2015

Enrollment Period

8 months

First QC Date

April 26, 2014

Last Update Submit

August 4, 2015

Conditions

Pancreatic Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (1)

  • Pancreatic fistula rate

    up to 30 days

Secondary Outcomes (1)

  • Mortality rate

    up to 30 days

Other Outcomes (8)

  • Intra-operative bleeding volume

    intra operative

  • Operation Time

    Intra operative

  • Conversion rate to open surgery

    Intra operative

  • +5 more other outcomes

Study Arms (3)

robotic arm

EXPERIMENTAL

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

Procedure: Robotic surgery

Laparoscopic surgery

EXPERIMENTAL

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

Procedure: Laparoscopic surgery

Open surgery

EXPERIMENTAL

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

Procedure: Open surgery

Interventions

Robotic surgeryPROCEDURE

Robotic surgery: enucleation benign Pancreatic Neuroendocrine Tumors

robotic arm
Laparoscopic surgeryPROCEDURE

Laparoscopic surgery: enucleation benign Pancreatic Neuroendocrine Tumors

Laparoscopic surgery
Open surgeryPROCEDURE

Open surgery: enucleation benign Pancreatic Neuroendocrine Tumors

Open surgery

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of General Surgery, Peking Union medical school hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (1)

  • Tian F, Hong XF, Wu WM, Han XL, Wang MY, Cong L, Dai MH, Liao Q, Zhang TP, Zhao YP. Propensity score-matched analysis of robotic versus open surgical enucleation for small pancreatic neuroendocrine tumours. Br J Surg. 2016 Sep;103(10):1358-64. doi: 10.1002/bjs.10220. Epub 2016 Aug 2.

    PMID: 27480993DERIVED

MeSH Terms

Interventions

Robotic Surgical ProceduresLaparoscopyConversion to Open Surgery

Intervention Hierarchy (Ancestors)

Surgery, Computer-AssistedSurgical Procedures, OperativeRoboticsAutomationTechnologyTechnology, Industry, and AgricultureEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical Procedures

Study Officials

  • Yupei Zhao, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2014

First Posted

April 29, 2014

Study Start

April 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

August 6, 2015

Record last verified: 2015-08

Locations

CN(1)