Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000882628
Ethics application status
Approved
Date submitted
27/07/2014
Date registered
20/08/2014
Date last updated
18/05/2016
Type of registration
Retrospectively registered

Titles & IDs
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
Secondary ID [1] 285062 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Confirmed or suspected borderline or benign tumors of the pancreatic neck and body 292586 0
Condition category
Condition code
Surgery 292890 292890 0 0
Surgical techniques
Oral and Gastrointestinal 293033 293033 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 289899 0
Treatment: Surgery
Comparator / control treatment
Open middle pancreatectomy
Open middle Pancreatectomy (MP) is a major traditional surgical operation for borderline or benign tumor of pancreatic neck and body.
Approximate duration required to complete open MP is about 180minutes.
Control group
Active

Outcomes
Primary outcome [1] 296608 0
Length of hospital stay are calculated by subtracting day of admission from day of discharge.
Timepoint [1] 296608 0
From admission to discharge
Secondary outcome [1] 309622 0
Short-term oncologic outcome are assessed included histological classification, tumor size, number of lymph nodes resected, TNM staging, resection margin cleaness
Timepoint [1] 309622 0
Immediately after surgery
Secondary outcome [2] 309623 0
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.
Timepoint [2] 309623 0
Immediately after surgery
Secondary outcome [3] 309624 0
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.
Timepoint [3] 309624 0
Immediately after hospital admission
Secondary outcome [4] 309625 0
Pancreatic fistular is assessed in accordance with the International Study Group for Pancreatic Fistula (ISGPF) criteria
Timepoint [4] 309625 0
Immediately after surgery
Secondary outcome [5] 309626 0
Nutritional states included total protein, pre-albumin, and hemoglobin
which are assessed according to blood routine examination and comprehensive metabolic panel
Timepoint [5] 309626 0
Monitored on a daily basis from the first postoperative day until the twentieth postoperative day
Secondary outcome [6] 318922 0
Morbidities are assessed according to the Clavien-Dindo classification system
Timepoint [6] 318922 0
Immediately after surgery in hospital stay
Secondary outcome [7] 323904 0
Operative time in surgery was assessed by operation room timer
Timepoint [7] 323904 0
From skin incision to wound closure
Secondary outcome [8] 323905 0
Blood loss in surgery was assessed by electric-drive sucker
Timepoint [8] 323905 0
From skin incision to wound closure

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients voluntarily gave informed consent prior to participation in this study. Randomization was performed using consecutive sealed opaque envelopes which contained randomized numbers and occurred before surgery.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The primary endpoint was the overall length of hospital stay (LOS), are calculated by subtracting day of admission from day of discharge. For the primary endpoint, estimates for standard deviation (SD) and minimal clinically relevant difference were derived from the existing literature. For the sample size calculation, a postulated time saving of 6 days was considered clinically relevant. The SD for postoperative hospital stay is known to be about 9 days. Calculations were based on a power of 80% and an a error of 5%, a number of at least 40 patients for each group was necessary. Anticipating a dropout rate of 10% and intended using nonparametric statistics, we increased the sample size to 50 patients per arm.The statistical software SPSS 19.0 (SPSS Inc., Chicago, IL, USA) was used for the statistical analysis. Continuous data are expressed as mean +/- standard deviation (SD) or median (interquartile range, IQR). Normally distributed variables were compared using the two independent samples Student t test. The Mann-Whitney U test was used for non-normally distributed variables. Categorical data were expressed as n (%) and compared using the chi-square test or Fisher’s exact test. Multivariate logistic regression analyses were performed for primary endpoint and pancreatic fistula, which were expressed as odd ratios (OR) with corresponding 95% confidence intervals (CI). A P-value less than 0.05 was considered statistically significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2011
Actual
1/08/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 6255 0
China
State/province [1] 6255 0
Shanghai

Funding & Sponsors
Funding source category [1] 289667 0
Government body
Name [1] 289667 0
National Health and Family Planning Commision of the People's Republic of
China (Funding name: Health industry research projects 201002020)
Country [1] 289667 0
China
Primary sponsor type
Hospital
Name
Ruijin Hospital
Address
No.197 Ruijin Er Road, Huangpu District, Shanghai.200025
Country
China
Secondary sponsor category [1] 288358 0
University
Name [1] 288358 0
Shanghai Jiaotong University School of Medicine
Address [1] 288358 0
No.280 Chongqin Nan Road , Huangpu District, Shanghai. 200025
Country [1] 288358 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291404 0
Ethics Committee of Shanghai Jiaotong University School of Medicine
Ethics committee address [1] 291404 0
Ethics committee country [1] 291404 0
China
Date submitted for ethics approval [1] 291404 0
30/06/2011
Approval date [1] 291404 0
31/07/2011
Ethics approval number [1] 291404 0
2012 No.75

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50242 0
Prof Cheng-hong Peng
Address 50242 0
Ruijin Hospital,No.197 Rui Jin Er Road, Huangpu District, Shanghai.
200025
Country 50242 0
China
Phone 50242 0
+86 021 64370045-360502
Fax 50242 0
Email 50242 0
[email protected]
Contact person for public queries
Name 50243 0
Shi Chen
Address 50243 0
Ruijin Hospital,No.197 Rui Jin Er Road, Huangpu District, Shanghai.
200025
Country 50243 0
China
Phone 50243 0
+86 021 64370045-360502
Fax 50243 0
Email 50243 0
[email protected]
Contact person for scientific queries
Name 50244 0
Bai-yong Shen
Address 50244 0
Ruijin Hospital,No.197 Rui Jin Er Road, Huangpu District, Shanghai.
200025
Country 50244 0
China
Phone 50244 0
+86 021 64370045-360502
Fax 50244 0
Email 50244 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRobot-assisted laparoscopic versus open middle pancreatectomy: short-term results of a randomized controlled trial.2017https://dx.doi.org/10.1007/s00464-016-5046-z
N.B. These documents automatically identified may not have been verified by the study sponsor.