Robotic-assisted middle pancreatectomy versus open middle pancreatectomy in patients with benign or borderline tumor of pancreatic neck and body: A randomized controlled trial

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000882628
• Date of registration: 20/08/2014
• Prospective Registration: No
• Primary sponsor: Ruijin Hospital
• Public title: Robotic-assisted middle pancreatectomy versus open middle pancreatectomy in patients with benign or borderline tumor of pancreatic neck and body: A randomized controlled trial
• Scientific title: Short-term efficacy of robotic-assisted middle pancreatectomy versus open middle pancreatectomy in patients with benign or borderline tumor of pancreatic neck and body: A randomized controlled trial
• Date of first enrolment: 01/08/2011
• Target sample size: 100
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12614000882628.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

China

Contacts

• Name: Dr Shi Chen

• Name: Prof Bai-yong Shen

Key inclusion & exclusion criteria

Inclusion criteria: (1) a tumor in the middle pancreas that was at least 5 cm from the pancreatic tail and might involve the pancreatic duct; (2) a tumor size less than 10 cm; (3) a benign or borderline tumor, such as an endocrine tumor, a serous or mucinous adenoma, a noninvasive intraductal papillary tumor (IPMTs) or a solid-pseudopapillary tumor (SPTs); and (4) pancreatic cystic tumors (lymphoepithelial cysts, dermoid cysts and hydatid cysts) that would be difficult to excise locally.
Exclusion criteria: (1) had severe underlying cardiopulmonary disease with poor heart and lung function, (2) could not tolerate anesthesia, (3) had a previous history of abdominal surgery that had resulted in severe abdominal adhesions, (4) scheduled for surgical treatment other than middle pancreatectomy such as distal pancreatectomy, (5) refusal to participate in or withdrawing from this study

Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Surgery - Surgical techniques

Confirmed or suspected borderline or benign tumors of the pancreatic neck and body;
Confirmed or suspected borderline or benign tumors of the pancreatic neck and body

Intervention(s)

Robotic-assisted middle pancreatectomy
Robot-assisted laparoscopy is the most advanced minimally invasive surgery technique characteristic of a magnified three-dimensional visualization and endowrist instruments with greater range of motion.Middle Pancreatectomy (MP) is a major surgical operation for borderline or benign tumor of pancreatic neck and body.
Approximate duration required to complete robotic-assisted
MP is about 200minutes.

Primary Outcome(s)

Length of hospital stay are calculated by subtracting day of admission from day of discharge.[From admission to discharge]

Secondary Outcome(s)

Recovery variables included times to resume off-bed activities, bowel movement and oral intake are assessed according to the review of
patient's medical records.[Immediately after surgery]

Pancreatic fistular is assessed in accordance with the International Study Group for Pancreatic Fistula (ISGPF) criteria[Immediately after surgery]

Operative time in surgery was assessed by operation room timer[From skin incision to wound closure]

Short-term oncologic outcome are assessed included histological classification, tumor size, number of lymph nodes resected, TNM staging, resection margin cleaness
[Immediately after surgery]

Nutritional states included total protein, pre-albumin, and hemoglobin
which are assessed according to blood routine examination and comprehensive metabolic panel[Monitored on a daily basis from the first postoperative day until the twentieth postoperative day]

Morbidities are assessed according to the Clavien-Dindo classification system[Immediately after surgery in hospital stay]

Patient characteristics included age, gender, body mass index (BMI), American Society of Anesthesiologists score (ASA), presence of diabetes mellitus (DM), hypertension, cardiac and pulmonary disease are assessed according to the review of patient's medical records.[Immediately after hospital admission]

Blood loss in surgery was assessed by electric-drive sucker[From skin incision to wound closure]

Secondary ID(s)

None

Source(s) of Monetary Support

National Health and Family Planning Commision of the People's Republic of China (Funding name: Health industry research projects 201002020)

Secondary Sponsor(s)

Shanghai Jiaotong University School of Medicine

Ethics review

Status: Approved
Approval date:
Contact:

Ethics Committee of Shanghai Jiaotong University School of Medicine