Standard Versus Extended Lymphadenectomy in Pancreatoduodenectomy for Patients With Pancreatic Head Adenocarcinoma
1 other identifier
interventional
320
1 country
1
Brief Summary
The aim of this study is to determine whether the performance of extended lymphadenectomy in association with pancreatoduodenectomy improves the long-term survival in patients with pancreatic head ductal adenocarcinoma.Half of participants will receive pancreatoduodenectomy with extended lymphadenectomy,while the other half will receive pancreatoduodenectomy with standard lymphadenectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 6, 2016
CompletedFirst Posted
Study publicly available on registry
October 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedOctober 7, 2016
October 1, 2016
5.1 years
October 6, 2016
October 6, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
5-year overall survival rate
The percentage of patients that are alive at a 5 year
5 years
Secondary Outcomes (9)
Postoperative pancreatic fistula
Within 30 days or before discharge
Bile leakage
Within 30 days or before discharge
Delayed gastric emptying
Within 30 days or before discharge
Post-pancreatectomy haemorrhage
Within 30 days or before discharge
Intra-abdominal infection
Within 30 days or before discharge
- +4 more secondary outcomes
Study Arms (2)
Extended lymphadenectomy
EXPERIMENTALIn addition to the standard lymphadenectomy, the nerve tissues around CHA and the SMA and nodes around the celiac trunk and SMA (No.16a2, 16b1) must be dissected. Retroperitoneal lymphatic tissue, nerves and connective tissue range from the hepatic portal down to the beginning part of the inferior mesenteric artery, the right to the right renal hilus, left to the left edge of the abdominal aorta is included.
Standard lymphadenectomy
OTHERLymph node dissection includes the superior and inferior pyloric nodes (LN5, LN6), anterior and posterior nodes along the common hepatic artery (CHA) (LN8a, 8b), nodes along the common hepatic duct, common bile duct and cystic duct (LN12b1, 12b2, 12c), posterior pancreatoduodenal nodes (LN13a, 13b), nodes along the superior mesenteric artery (SMA) (LN14a, 14b), anterior pancreatoduodenal nodes (LN17a, 17b), but excluding the nerve tissues around common hepatic artery and the superior mesenteric artery.
Interventions
Extended lymphadenectomy with nerve tissues around CHA and the SMA and nodes around the celiac trunk and SMA (No.16a2, 16b1)
Lymph node dissection includes(LN5, LN6),(LN8a, 8b),(LN12b1, 12b2, 12c),(LN13a, 13b),(LN14a, 14b),(LN17a, 17b)
Eligibility Criteria
You may qualify if:
- Subject was diagnosed with pancreatic ductal adenocarcinoma supported by pathological and radiological examination preoperatively
- Subject with absence of vascular invasion and metastasis
- Subject with absence of prior history of cancer
You may not qualify if:
- Subject was diagnosed that other pancreatic tumour types (neuroendocrine tumors, intraductal papillary mucinous neoplasm, serous cystadenoma, mucinous cystadenocarcinoma, solid pseudopapillary neoplasm and pancreatitis)
- Subject was found with liver, omental, mesenteric or peritoneal metastasis intraoperatively
- Subject with presence of other significant diseases (e.g., coronary heart disease)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- West China Hospitallead
- Royal Liverpool University Hospitalcollaborator
Study Sites (1)
West China Hospital
Chengdu, Sichuan, 610041, China
Related Publications (8)
Xiong J, Szatmary P, Huang W, de la Iglesia-Garcia D, Nunes QM, Xia Q, Hu W, Sutton R, Liu X, Raraty MG. Enhanced Recovery After Surgery Program in Patients Undergoing Pancreaticoduodenectomy: A PRISMA-Compliant Systematic Review and Meta-Analysis. Medicine (Baltimore). 2016 May;95(18):e3497. doi: 10.1097/MD.0000000000003497.
PMID: 27149448BACKGROUNDXiong JJ, Tan CL, Szatmary P, Huang W, Ke NW, Hu WM, Nunes QM, Sutton R, Liu XB. Meta-analysis of pancreaticogastrostomy versus pancreaticojejunostomy after pancreaticoduodenectomy. Br J Surg. 2014 Sep;101(10):1196-208. doi: 10.1002/bjs.9553. Epub 2014 Jul 16.
PMID: 25042895BACKGROUNDChen Y, Ke N, Tan C, Zhang H, Wang X, Mai G, Liu X. Continuous versus interrupted suture techniques of pancreaticojejunostomy after pancreaticoduodenectomy. J Surg Res. 2015 Feb;193(2):590-7. doi: 10.1016/j.jss.2014.07.066. Epub 2014 Aug 5.
PMID: 25175768RESULTChen Y, Tan C, Mai G, Ke N, Liu X. Resection of pancreatic tumors involving the anterior surface of the superior mesenteric/portal veins axis: an alternative procedure to pancreaticoduodenectomy with vein resection. J Am Coll Surg. 2013 Oct;217(4):e21-8. doi: 10.1016/j.jamcollsurg.2013.07.383. No abstract available.
PMID: 24054418RESULTChen Y, Wang X, Ke N, Mai G, Liu X. Inferior mesenteric vein serves as an alternative guide for transection of the pancreatic body during pancreaticoduodenectomy with concomitant vascular resection: a comparative study evaluating perioperative outcomes. Eur J Med Res. 2014 Aug 21;19(1):42. doi: 10.1186/s40001-014-0042-z.
PMID: 25141915RESULTNimura Y, Nagino M, Takao S, Takada T, Miyazaki K, Kawarada Y, Miyagawa S, Yamaguchi A, Ishiyama S, Takeda Y, Sakoda K, Kinoshita T, Yasui K, Shimada H, Katoh H. Standard versus extended lymphadenectomy in radical pancreatoduodenectomy for ductal adenocarcinoma of the head of the pancreas: long-term results of a Japanese multicenter randomized controlled trial. J Hepatobiliary Pancreat Sci. 2012 May;19(3):230-41. doi: 10.1007/s00534-011-0466-6.
PMID: 22038501RESULTJang JY, Kang MJ, Heo JS, Choi SH, Choi DW, Park SJ, Han SS, Yoon DS, Yu HC, Kang KJ, Kim SG, Kim SW. A prospective randomized controlled study comparing outcomes of standard resection and extended resection, including dissection of the nerve plexus and various lymph nodes, in patients with pancreatic head cancer. Ann Surg. 2014 Apr;259(4):656-64. doi: 10.1097/SLA.0000000000000384.
PMID: 24368638RESULTWang Z, Ke N, Wang X, Wang X, Chen Y, Chen H, Liu J, He D, Tian B, Li A, Hu W, Li K, Liu X. Optimal extent of lymphadenectomy for radical surgery of pancreatic head adenocarcinoma: 2-year survival rate results of single-center, prospective, randomized controlled study. Medicine (Baltimore). 2021 Sep 3;100(35):e26918. doi: 10.1097/MD.0000000000026918.
PMID: 34477122DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hongyu Chen, MD
West China Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Hongyu Chen,MD
Study Record Dates
First Submitted
October 6, 2016
First Posted
October 7, 2016
Study Start
January 1, 2016
Primary Completion
February 1, 2021
Study Completion
April 1, 2021
Last Updated
October 7, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share