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NCT Number: NCT02125929

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

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

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Key information

Conditions

Pancreatic Neuroendocrine Tumors

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of General Surgery, Peking Union medical school hospital

Beijing, Beijing Municipality, 100730, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robotic surgery

Procedure

Robotic surgery: enucleation benign Pancreatic Neuroendocrine Tumors

Laparoscopic surgery

Procedure

Laparoscopic surgery: enucleation benign Pancreatic Neuroendocrine Tumors

Open Surgery

Procedure

Open surgery: enucleation benign Pancreatic Neuroendocrine Tumors

Primary outcomes

  1. Pancreatic fistula rate

    Time frame: up to 30 days

Secondary outcomes

  1. Mortality rate

    Time frame: up to 30 days

Other outcomes

  1. Intra-operative bleeding volume

    Time frame: intra operative

  2. Operation Time

    Time frame: Intra operative

  3. Conversion rate to open surgery

    Time frame: Intra operative

    Only applied to the robotic surgery arm and laparoscopic arm

  4. Quality of life and pain scores

    Time frame: up to 30 days

  5. Delayed gastric emptying rate

    Time frame: up to 30 days

  6. Intra-abdominal bleeding rate

    Time frame: up to 30 days

  7. Postoperative infection rate

    Time frame: up to 30 days

  8. Hospital stay time

    Time frame: up to 30 days

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 29, 2014
Registry last updated
Aug 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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