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Trial registered on ANZCTR


Registration number
ACTRN12616000854437
Ethics application status
Approved
Date submitted
12/05/2016
Date registered
29/06/2016
Date last updated
12/09/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Lymphadenectomy for Pancreatic Head Cancer: Standard or Extended?
Scientific title
A Prospective Randomized Controlled Study Comparing Standard and Extended Lymphadenectomy for Pancreatic Head Cancer
Secondary ID [1] 289198 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic ductal adenocarcinoma 298747 0
pancreaticoduodenectomy 298748 0
Lymphadenectomy 298749 0
Condition category
Condition code
Surgery 298800 298800 0 0
Surgical techniques
Cancer 299011 299011 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pancreaticoduodenectomy for Pancreatic ductal adenocarcinoma with standard or extended lymphadenectomy undergoing by the surgeons from Ruijin Hospital
standard lymphadenectomy includes standard lymphadenectomy and No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b lymph nodes stations
extended lymphadenectomy includes No8p 12a 12p 14c 14d 16 lymph nodes stations and those in standard lymphadenectomy( No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b)
The details of all lymph nodes stations are described as below:
No. 5, Suprapyloric lymph nodes; No. 6, infrapyloric lymph nodes; No. 8a, lymph nodes in the anterosuperior group along the common hepatic artery; No. 8p, lymph nodes in the posterior group along the common hepatic artery; No. 12a, lymph nodes along the hepatic artery; No. 12p, lymph nodes along the portal vein; No. 12b, lymph nodes along the bile duct; No. 12c (located next to 12b), lymph nodes around the cystic duct; No. 13a, lymph nodes on the posterior aspect of the superior portion of the head of the pancreas; No. 13b, lymph nodes on the posterior aspect of the inferior portion of the head of the pancreas; No. 14, lymph nodes along the superior mesenteric artery (a & b. right lateral side, c & d. left lateral side ); No. 16, lymph nodes around the abdominal aorta;.No. 17a, lymph nodes on the anterior surface of the superior portion of the head of the pancreas; No. 17b, lymph nodes on the anterior surface of the inferior portion of the head of the pancreas
Intervention code [1] 294726 0
Treatment: Surgery
Comparator / control treatment
Standard resection/ extended resection
standard lymphadenectomy includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b lymph nodes stations
extended lymphadenectomy includes standard lymphadenectomy and No8p 12a 12p 14c 14d 16 lymph nodes stations.
Control group
Active

Outcomes
Primary outcome [1] 298267 0
All-cause mortality/ overall survial
Medical records, the follow-ups
Timepoint [1] 298267 0
1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months after operation
Primary outcome [2] 298476 0
Disease free survival (DFS)
test: blood test for tumor marker (includes:CA199, CA125, CEA, AFP, etc); biopsy (evidence of metastasis or recurrence), etc.
medical examination: scanner (CT), PET-CT; etc.
Timepoint [2] 298476 0
1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months after operation
Secondary outcome [1] 324857 0
Incidence of post-operative complications
(includes pancreatic fistula, biliary fistula, abdominal infection, hemorrhage, etc)
test: blood routine, drain fluid amylase, blood culture, scanner(CT), etc.
Timepoint [1] 324857 0
Duration of hospital stay

Eligibility
Key inclusion criteria
1. Pathologic diagnosis of pancreatic ductal adenocarcinoma
2. Signed the informed consents
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pathologic diagnosis of other pancreatic cancers
2.pre-operative anti-cancer treatment
3. recurrence patients
4.patients with contraindication(hepatic/ respiratory/ renal dysfunction, etc )
5.pre operative exam: Total bilirubine > 250micromol/L
6. AJCC stage IV
7.operation non radical

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/06/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
89
Final
Recruitment outside Australia
Country [1] 7870 0
China
State/province [1] 7870 0
Shanghai

Funding & Sponsors
Funding source category [1] 293570 0
Commercial sector/Industry
Name [1] 293570 0
Shanghai hospital development center
Country [1] 293570 0
China
Primary sponsor type
Hospital
Name
Shanghai Ruijin Pancreatic Disease Center
Address
No 197 ruijin er road shanghai china 200025
Country
China
Secondary sponsor category [1] 292392 0
Individual
Name [1] 292392 0
Baiyong SHEN
Address [1] 292392 0
No 197 ruijin er road, Shanghai Ruijin Pancreatic Disease Center, Shanghai Ruijin Hospital, shanghai china 200025
Country [1] 292392 0
China
Secondary sponsor category [2] 292393 0
Individual
Name [2] 292393 0
Weishen WANG
Address [2] 292393 0
No 197 ruijin er road, Shanghai Ruijin Pancreatic Disease Center, Shanghai Ruijin Hospital, shanghai china 200025
Country [2] 292393 0
China
Other collaborator category [1] 278993 0
Hospital
Name [1] 278993 0
Shanghai Zhongshan Hospital
Address [1] 278993 0
No.180 Fenglin Road Shanghai, 200032
Country [1] 278993 0
China
Other collaborator category [2] 278994 0
Hospital
Name [2] 278994 0
Shanghai Xinhua Hospital
Address [2] 278994 0
No. 1665 Kongjiang Rd, Shanghai, China, 200093
Country [2] 278994 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295016 0
Ruijin hospital ethics committee confidential agreement
Ethics committee address [1] 295016 0
Ethics committee country [1] 295016 0
China
Date submitted for ethics approval [1] 295016 0
19/02/2016
Approval date [1] 295016 0
01/03/2016
Ethics approval number [1] 295016 0

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

Contacts
Principal investigator
Name 65802 0
Dr Weishen WANG
Address 65802 0
No. 197 Ruijin Er Road Shanghai, Shanghai Ruijin Pancreatic Disease Center, Shanghai Ruijin Hospital, Shanghai, P.R China, 200025
Country 65802 0
China
Phone 65802 0
+86 21 64370045*362174
Fax 65802 0
Email 65802 0
peanutswey@hotmail.com
Contact person for public queries
Name 65803 0
Yuchen Yang
Address 65803 0
No. 197 Ruijin Er Road Shanghai, Shanghai Ruijin Pancreatic Disease Center, Shanghai Ruijin Hospital, Shanghai, P.R China, 200025
Country 65803 0
China
Phone 65803 0
+86 13901855633
Fax 65803 0
Email 65803 0
89371481@qq.com
Contact person for scientific queries
Name 65804 0
Baiyong SHEN
Address 65804 0
No. 197 Ruijin Er Road Shanghai, Shanghai Ruijin Pancreatic Disease Center, Shanghai Ruijin Hospital, Shanghai, P.R China, 200025
Country 65804 0
China
Phone 65804 0
+86 21 6437 0045*671006
Fax 65804 0
Email 65804 0
shenby@shsmu.edu.cn

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
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