Clinical trial · Interventional
Standardization of Surgery on the Pancreatic Cancer
Randomized Controlled Study: Comparison Between Extended and Standard Pancreatoduodenectomy
NCT00679913CI-TRIAL-00014799completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study was designed to test the hypothesis that more extensive nodal and soft-tissue clearance in patients with adenocarcinoma of the head of the pancreas would improve survival without an increase in morbidity and mortality.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Extended pancreatoduodenectomy | Procedure | — | UNRESOLVED |
| Standard pancreatoduodenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- standard pancreatoduodenectomy
- interventionNames
- Procedure: Standard pancreatoduodenectomy
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- extended pancreatoduodenectomy
- interventionNames
- Procedure: Extended pancreatoduodenectomy
Primary outcomes (1)
- measure
- Survival
- timeFrame
- 2 year after surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Age : 20- 85 years old * No evidence of metastasis and to be possible to resect radically * No history of previous radiation therapy or chemotherapy * Pathological diagnosis: adenocarcinoma of pancreas * Patients who agree and sign the informed consent * More than 70 in Karnofsky performance scale Exclusion Criteria: * Past medical history of treatment for other malignant disease * Recurred pancreatic cancer patients * Patients with R1/R2 resection * Patients who underwent neoadjuvant chemotherapy
References
Publications (5)
- BACKGROUNDPedrazzoli S, DiCarlo V, Dionigi R, Mosca F, Pederzoli P, Pasquali C, Kloppel G, Dhaene K, Michelassi F. Standard versus extended lymphadenectomy associated with pancreatoduodenectomy in the surgical treatment of adenocarcinoma of the head of the pancreas: a multicenter, prospective, randomized study. Lymphadenectomy Study Group. Ann Surg. 1998 Oct;228(4):508-17. doi: 10.1097/00000658-199810000-00007. PMID 9790340
- BACKGROUNDYeo CJ, Cameron JL, Sohn TA, Coleman J, Sauter PK, Hruban RH, Pitt HA, Lillemoe KD. Pancreaticoduodenectomy with or without extended retroperitoneal lymphadenectomy for periampullary adenocarcinoma: comparison of morbidity and mortality and short-term outcome. Ann Surg. 1999 May;229(5):613-22; discussion 622-4. doi: 10.1097/00000658-199905000-00003. PMID 10235519
- BACKGROUNDFarnell MB, Pearson RK, Sarr MG, DiMagno EP, Burgart LJ, Dahl TR, Foster N, Sargent DJ; Pancreas Cancer Working Group. A prospective randomized trial comparing standard pancreatoduodenectomy with pancreatoduodenectomy with extended lymphadenectomy in resectable pancreatic head adenocarcinoma. Surgery. 2005 Oct;138(4):618-28; discussion 628-30. doi: 10.1016/j.surg.2005.06.044. PMID 16269290
- BACKGROUNDMichalski CW, Kleeff J, Wente MN, Diener MK, Buchler MW, Friess H. Systematic review and meta-analysis of standard and extended lymphadenectomy in pancreaticoduodenectomy for pancreatic cancer. Br J Surg. 2007 Mar;94(3):265-73. doi: 10.1002/bjs.5716. PMID 17318801
- DERIVEDJang 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 24368638