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Lymphadenectomy for Pancreatic Head Cancer: Standard or Extended?

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02787187
Enrollment
230
Registered
2016-06-01
Start date
2016-07-01
Completion date
2021-10-31
Last updated
2021-11-23

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

Conditions

Pancreatic Ductal Adenocarcinoma

Keywords

Standard lymphadenectomy, extended lymphadenectomy, pancreaticoduodenectomy

Brief summary

The purpose of this study is to compare outcomes of patients undergoing standard or extended lymphadenectomy in pancreaticoduodenectomy for pancreatic cancer

Interventions

PROCEDUREPancreaticoduodenectomy with Standard lymphadenectomy

Pancreaticoduodenectomy:child's digestive reconstruction standard lymphadenectomy: No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b

PROCEDUREPancreaticoduodenectomy with Extended lymphadenectomy

Pancreaticoduodenectomy:child's digestive reconstruction extended lymphadenectomy: No8p 12a 12p 14c 14d 16

Sponsors

Shanghai Zhongshan Hospital
CollaboratorOTHER
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
CollaboratorOTHER
Ruijin Hospital
Lead SponsorOTHER

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 80 Years
Healthy volunteers
No

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

MeasureTime frame
All-cause mortality3yrs post-operation

Secondary

MeasureTime frame
all-cause mortality1yr post-operation

Countries

China

Outcome results

None listed

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