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Trial registered on ANZCTR


Registration number
ACTRN12614000299606
Ethics application status
Approved
Date submitted
10/03/2014
Date registered
20/03/2014
Date last updated
17/07/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of robot-assisted laparoscopic pancreaticoduodenectomy and open pancreaticoduodenectomy: a Prospective, Non-randomized Controlled Study
Scientific title
A comparison of Robot-assisted Laparoscopic Pancreaticoduodenectomy and Open Pancreaticoduodenectomy in patients with benign, borderline and malignant pathologies of the pancreatic head, distal common bile duct and periampullary region: A Prospective, matched Controlled Study in China
Secondary ID [1] 284230 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 malignant pathologies of the pancreatic head, distal common bile duct and periampullary region . 291343 0
Condition category
Condition code
Surgery 291706 291706 0 0
Surgical techniques
Cancer 291765 291765 0 0
Pancreatic
Cancer 291766 291766 0 0
Biliary tree (gall bladder and bile duct)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Robotic-assisted pancreaticoduodenectomy
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.Pancreaticoduodenectomy (PD) is a major surgical operation involving the pancreas, duodenum, and pylorus in most cases.
Approximate duration required to complete robotic-assisted pancreaticoduodenectomy is about 410minutes.
Intervention code [1] 288936 0
Treatment: Surgery
Comparator / control treatment
Open pancreaticoduodenectomy
Pancreaticoduodenectomy (PD), also called Whipple procedure, is a major surgical operation involving the pancreas, duodenum, and pylorus in most cases first described in 1938 for treating borderline or malignant pancreatic head, common bile duct, and duodenal pathologies.
Approximate duration required to complete open pancreaticoduodenectomy is about 315 minutes.
Control group
Active

Outcomes
Primary outcome [1] 291644 0
Operative time in surgery was assessed by operation room timer
Timepoint [1] 291644 0
From skin incision to wound closure
Primary outcome [2] 291694 0
Blood loss in surgery was assessed by electric-drive sucker
Timepoint [2] 291694 0
From skin incision to wound closure
Primary outcome [3] 291695 0
Morbidities are assessed according to the Clavien-Dindo classification system
Timepoint [3] 291695 0
Immediately after surgery in hospital stay
Secondary outcome [1] 307219 0
Long-term oncologic outcome at 5 years(overall survival) are assessed according to the review of patient's medical records
Timepoint [1] 307219 0
Follow-up lasted until death or the cutoff date of March 1, 2014
Secondary outcome [2] 307305 0
Long-term oncologic outcome at 5 years(disease-free survival) are assessed according to the review of patient's medical records
Timepoint [2] 307305 0
Follow-up lasted until death or the cutoff date of June 30, 2014
Secondary outcome [3] 307306 0
Nutritional states included total protein, pre-albumin, and hemoglobin which are assessed according to blood routine examination and comprehensive metabolic panel.
Timepoint [3] 307306 0
Monitored on a daily basis from the first postoperative day until the twentieth postoperative day
Secondary outcome [4] 307307 0
Short-term oncologic outcome are assessed included histological classification, tumor size, number of lymph nodes resected, TNM staging, resection margin cleaness
Timepoint [4] 307307 0
Immediately after surgery
Secondary outcome [5] 307308 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 [5] 307308 0
Immediately after surgery
Secondary outcome [6] 307309 0
Cost analysis included operative time and supplies, anesthesia, nursing, laboratory, and overall hospital stay costs
Timepoint [6] 307309 0
Immediately after hospital admission
Secondary outcome [7] 307310 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 [7] 307310 0
Immediately after hospital admission
Secondary outcome [8] 307311 0
Pancreatic fistular is assessed in accordance with the International Study Group for Pancreatic Fistula (ISGPF) criteria
Timepoint [8] 307311 0
Immediately after surgery

Eligibility
Key inclusion criteria
Being at least 18 years old; a resectable malignant or borderline malignant pathology of the pancreatic head (including stage I and II pancreatic cancer), distal common bile duct, or periampullary region in accordance with the National Comprehensive Cancer Network (NCCN) Guidelines; and having received no neoadjuvant chemoradiation therapy.
Minimum age
18 Years
Maximum age
77 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Having an excessively large lesion (tumor size >10 cm) invading adjacent organs and major vessels; involvement of superior mesenteric vein or portal vein (PV) longer than 3 cm possibly requiring interposed graft reconstruction, for which OPD was determined to be more suitable than RLDP; scheduled for surgical treatment other than PD, such as palliative biliary and gastroenteric anastomoses; presence of complicating serious cardiopulmonary or hepatorenal insufficiency; extensive intraperitoneal or extraperitoneal metastases; and refusal to participate in or withdrawing from this study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The RLPD group was matched with the OPD group at a ratio of 1:2 using a matching patient’s algorithm according to age (within ± 5 years), sex, body mass index (BMI; <18.5 versus 18.5–24.9 versus 25.0–29.9 versus = 30 kg/m2), American Society of Anesthesiologists (ASA) physical status classification (I versus II versus III), and malignancy (malignant vs. non-malignant), location (pancreas versus distal common bile duct versus periampullary region) and size of tumor. The matching process was verified every 2 enrolments in the RLPD group to allow targeted recruitment into the OPD group. All patients included were well informed of the advantages and disadvantages of RLPD and OPD by independent research nurses. All patients voluntarily gave written informed consent for participation in this study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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 statistical software SPSS 19.0 (SPSS Inc., Chicago, IL, USA) was used for the statistical analysis. Continuous data were expressed as mean +/- standard deviation (SD), and the means were compared using the two independent samples Student-t test. Categorical data were expressed as n(%) and compared using the Fisher’s exact probability test. The Mann-Whitney U test was used for non-normally distributed variables. The linear regression was used to analyze whether demographic growth exhibited significance. The Spearman rank correlation coefficient was used to determine whether operative time, bleeding volume and morbidity rate exhibited significant ‘‘learning curves’’. Survival analysis was performed using the time between the date of surgery and the date of last follow-up or death. Survival curves were computed using the Kaplan-Meier method and compared between groups by the log-rank test. A P-value less than 0.05 was considered statistically significant.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/01/2010
Actual
1/01/2010
Date of last participant enrolment
Anticipated
31/12/2013
Actual
31/12/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
326
Accrual to date
Final
Recruitment outside Australia
Country [1] 5879 0
China
State/province [1] 5879 0
Shanghai

Funding & Sponsors
Funding source category [1] 288858 0
Government body
Name [1] 288858 0
National Health and Family Planning Commision of the People's Republic of China (Funding name: Ministry of Health Sector Funds 201002020)
Country [1] 288858 0
China
Primary sponsor type
Hospital
Name
Ruijin Hospital
Address
No.197 Ruijin Second Road, Huangpu District, Shanghai.200025, China
Country
China
Secondary sponsor category [1] 287554 0
University
Name [1] 287554 0
Shanghai Jiaotong University School of Medicine
Address [1] 287554 0
No.280 Chongqin South Road , Huangpu District, Shanghai. 200025, China
Country [1] 287554 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290690 0
Ethics Committee of Shanghai Jiaotong University School of Medicine
Ethics committee address [1] 290690 0
Ethics committee country [1] 290690 0
China
Date submitted for ethics approval [1] 290690 0
01/12/2009
Approval date [1] 290690 0
01/01/2010
Ethics approval number [1] 290690 0
2012-75

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

Contacts
Principal investigator
Name 46810 0
Dr ChengHong Peng
Address 46810 0
Ruijin Hospital,No.197 Rui Jin Second Road, Huangpu District, Shanghai. 200025, China
Country 46810 0
China
Phone 46810 0
+86 021 64370045-360502
Fax 46810 0
Email 46810 0
[email protected]
Contact person for public queries
Name 46811 0
Shi Chen
Address 46811 0
Ruijin Hospital,No.197 Rui Jin Second Road, Huangpu District, Shanghai.200025, China
Country 46811 0
China
Phone 46811 0
+86 021 64370045-360502
Fax 46811 0
Email 46811 0
[email protected]
Contact person for scientific queries
Name 46812 0
Jiangzhi Chen
Address 46812 0
Ruijin Hospital,No.197 Rui Jin Second Road, Huangpu District, Shanghai.200025, China
Country 46812 0
China
Phone 46812 0
+86 021 64370045-360502
Fax 46812 0
Email 46812 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 pancreaticoduodenectomy: a prospective, matched, mid-term follow-up study.2015https://dx.doi.org/10.1007/s00464-015-4140-y
N.B. These documents automatically identified may not have been verified by the study sponsor.