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Standard Versus Extended Lymphadenectomy in Pancreatoduodenectomy for Patients With Pancreatic Head Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02928081
Recruitment Status : Recruiting
First Posted : October 7, 2016
Last Update Posted : October 7, 2016
Sponsor:
Collaborator:
Royal Liverpool University Hospital
Information provided by (Responsible Party):
Chen Hongyu, West China Hospital

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Pancreatic Ductal Procedure: Extended lymphadenectomy Procedure: Standard lymphadenectomy Not Applicable

Detailed Description:

Pancreatic cancer is a common malignant disease of the digestive system, and its incidence has been steadily increasing recently. Currently, the only potential curative treatment for pancreatic cancer is radical surgery. However, due to the peculiarity of the anatomical location of pancreas (in the retroperitoneum, surrounded by peripheral nerves and blood vessels) and its biological characteristics (neurotropic, highly malignant, and with probable skip metastasis), it is difficult to achieve R0 resection in patients with pancreatic cancer. High postoperative recurrence and distant metastasis rate are key factors in reducing long-term survival of patients with pancreatic cancer. The radical surgery modalities for pancreatoduodenectomy to achieve R0 resection involve extended lymphadenectomy, multivisceral resections, with or without simultaneous vein removals. Currently, the lymphadenectomy extent and approaches used to achieve R0 status are diverse. In 2014, the International Study Group for Pancreatic Surgery (ISGPS) reached a consensus to strive to resect lymph nodes (LNs) 5, 6, 8a, 12b1, 12b2, 12c, 13a, 13b, 14a, 14b, 17a, and 17b in standard lymphadenectomy for pancreatoduodenectomy. However, no consensus was reached on dissection of LN 16 due to variation in the literature and different expert opinions. On the current evidence, benefit of extended lymph node dissection seems to be outweighed by the risks. But deficiencies exist in the design of previous RCTs, such as insufficient sample size, lack of certain critical data for statistical analysis, inclusion of other pathological types of pancreatic neoplasms and variable retroperitoneal lymph node resection and nerve plexus dissection . Therefore, the power of evidence was low. Most studies report a high frequency of lymph node metastasis to LNs 13, 14, 17, 12 and 16 in pancreatic cancer, and tendency to metastasis from LNs 13, 14 to LN 16. In a lot of case reports, only nodal station 16a2 and 16b1 were positive in LN 16.

This study is performed to confirm whether pancreatoduodenectomy with extended lymphadenectomy could improve survival. Subjects undergoing surgery will be randomized to pancreatoduodenectomy with extended lymphadenectomy including nerve tissues around CHA and the SMA and nodes around the celiac trunk and SMA (No.16a2, 16b1) versus standard pancreatoduodenectomy. Subjects will be followed every three months for survivorship or death. The primary endpoint of 5-year overall or disease-free survival survival will be determined at five year post surgery.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Standard Versus Extended Lymphadenectomy in Pancreatoduodenectomy
Study Start Date : January 2016
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Extended lymphadenectomy
In 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.
Procedure: Extended lymphadenectomy
Extended lymphadenectomy with nerve tissues around CHA and the SMA and nodes around the celiac trunk and SMA (No.16a2, 16b1)

Standard lymphadenectomy
Lymph 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.
Procedure: Standard lymphadenectomy
Lymph node dissection includes(LN5, LN6),(LN8a, 8b),(LN12b1, 12b2, 12c),(LN13a, 13b),(LN14a, 14b),(LN17a, 17b)




Primary Outcome Measures :
  1. 5-year overall survival rate [ Time Frame: 5 years ]
    The percentage of patients that are alive at a 5 year


Secondary Outcome Measures :
  1. Postoperative pancreatic fistula [ Time Frame: Within 30 days or before discharge ]
    ISGPS definition

  2. Bile leakage [ Time Frame: Within 30 days or before discharge ]
    ISGLS definition

  3. Delayed gastric emptying [ Time Frame: Within 30 days or before discharge ]
    ISGPS definition

  4. Post-pancreatectomy haemorrhage [ Time Frame: Within 30 days or before discharge ]
    ISGPS definition

  5. Intra-abdominal infection [ Time Frame: Within 30 days or before discharge ]
    Presence of fever, signs of peritonitis, high leukocytes count or positive peritoneal drainage fluid culture

  6. Wound infection [ Time Frame: Within 30 days or before discharge ]
    Requiring invasive treatment, for example: positive wound exudate culture and requiring continuous re-open drainage or invasive treatment

  7. Postoperative mortality [ Time Frame: Within 30 days or 60 days ]
    Death due to any cause before or at postoperative day 30 and 60

  8. Quality of life [ Time Frame: 1 or 3 or 5 year ]
    EORTC QLQ-C30, according to the scoring manual published by the EORTC Quality of Life group

  9. 5-year disease-free survival rate [ Time Frame: 5 years ]
    The percentage of patients alive without recurrence at a 5 year



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02928081


Contacts
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Contact: Xubao Liu, MD 86-28-85422474 liuxb2011@126.com
Contact: Junjie Xiong, MD 86-28-85422474 junjiex2011@126.com

Locations
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China, Sichuan
West China Hospital Recruiting
Chengdu, Sichuan, China, 610041
Contact: Xubao Liu, MD    86-28-85422474    liuxb2011@126.com   
Contact: Junjie Xiong, MD    86-28-85422474    junjiex2011@126.com   
Principal Investigator: Junjie Xiong, MD         
Principal Investigator: Hongyu Chen, MD         
Sub-Investigator: Nengwen Ke, MD         
Sub-Investigator: Chunlu Tan, MD         
Sub-Investigator: Hao Zhang, MD         
Sub-Investigator: Ming Yang, MD         
Sub-Investigator: Bole Tian, MD         
Sub-Investigator: Weiming Hu, MD         
Sub-Investigator: Kezhou Li, MD         
Sponsors and Collaborators
West China Hospital
Royal Liverpool University Hospital
Investigators
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Principal Investigator: Hongyu Chen, MD West China Hospital

Publications of Results:

Other Publications:
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Responsible Party: Chen Hongyu, Hongyu Chen,MD, West China Hospital
ClinicalTrials.gov Identifier: NCT02928081    
Other Study ID Numbers: 2015267
First Posted: October 7, 2016    Key Record Dates
Last Update Posted: October 7, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Carcinoma, Pancreatic Ductal
Carcinoma, Ductal
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Ductal, Lobular, and Medullary
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases