Should a Standard Lymphadenectomy Include the No. 16 Lymph Nodes for Patients With Pancreatic Head Adenocarcinoma.

A Prospective Randomized Controlled Study Comparing Standard and Extended Lymphadenectomy for Pancreatic Head Cancer

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04115527

Enrollment

100

Registered

2019-10-04

Start date

2018-06-01

Completion date

2023-12-31

Last updated

2023-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Ductal Adenocarcinoma

Keywords

RCT, Standard lymphadenectomy, Extended lymphadenectomy, Pancreaticoduodenectomy

Brief summary

The aim of this study is to determine whether para-aortic lymph nodes(No.16) should be included in the lymphadenectomy during the pancreatoduodenectomy in order to improve the long-term survival of patients with pancreatic head ductal adenocarcinoma.

Detailed description

Pancreatic cancer is now raised to the 7th leading cause of death. Surgical resection seems to be the unique curative therapy for pancreatic cancer. The pancreaticoduodenectomy is widely performed for the patients with pancreatic head cancer in recent decades. The lymphadenectomy is an indispensible procedure. In 2014, the International Study Group for Pancreatic Surgery (ISGPS) recommended a standard lymphadenectomy should include lymph node stations 5, 6, 8a, 12b1, 12b2, 12c, 13a, 13b, 14a, 14b, 17a, and 17b. However, no consensus was reached on Lymph node 16 in particular 16b1. There was no stronge evidence available concerning the impact on survival.

Interventions

PROCEDUREExtended Lymphadenectomy

Lymph node dissection includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 16 17a 17b lymph nodes

PROCEDUREStandard Lymphadenectomy

Lymph node dissection includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b lymph nodes

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Pathologic diagnosis of pancreatic ductal adenocarcinoma * Signed the informed consents

Exclusion criteria

* Pathologic diagnosis of other pancreatic cancers * Pre-operative anti-cancer treatment * Recurrence patients * Patients with contraindication(hepatic/ respiratory/ renal dysfunction, etc ) * Pre operative exam: Total bilirubin more than 250µmol/L * AJCC stage IV * Operation non radical

Design outcomes

Primary

Measure	Time frame	Description
1 year overall survival rate	1 year post-operation	1 year overall survival rate
3 years overall survival rate	3 years post-operation	3 years overall survival rate
5 years overall survival rate	5 years post-operation	5 years overall survival rate

Secondary

Measure	Time frame	Description
Postoperative Complications	Within 90 days or before discharge	pancreatic fistula, bile leakage, haemorrhage, DGE, etc
1, 3 & 5 years disease free survival rate	1, 3 & 5 years post-operation	1, 3 & 5 years disease free survival rate

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026