Clinical trial · Interventional
Role of CTC´s Spread During Pancreaticoduodenectomy in Patients With Pancreatic and Periampullary Tumors
Role of Circulating Tumor Cells (CTC´s) Spread During Pancreaticoduodenectomy in Metastasis and Survival Rates in Patients With Pancreatic and Periampullary Tumors
NCT03340844CI-TRIAL-00077098CETUPANCcompletedN/AClinicalTrials.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 multicentre, prospective and randomized study aims(1:1) to compare the rate of recurrence, metastasis and survival according to the levels of intraoperative circulating tumor cells (CTCs) during cephalic duodenopancreatectomy in patients with pancreatic and periampullary tumors.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Circulating Tumor Cells | — | UNRESOLVED | — |
| Metastasis | — | UNRESOLVED | — |
| Pancreatic Tumor | Pancreatic Neoplasm | ALIAS | 0.90 |
| Periampullary Carcinoma Resectable | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Touch (NT) | Procedure | — | UNRESOLVED |
| Superior Mesenteric Artery First (SMA) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- No Touch (NT)
- description
- Pancreatic and Periampullary Tumors resection by no-touch technique
- interventionNames
- Procedure: No Touch (NT)
- type
- ACTIVE_COMPARATOR
- label
- Superior Mesenteric Artery First (SMA)
- description
- Pancreatic and Periampullary Tumors resection by superior Mesenteric Artery First technique
- interventionNames
- Procedure: Superior Mesenteric Artery First (SMA)
Primary outcomes (4)
- measure
- Circulating tumor cells (CTC´s)
- timeFrame
- During the surgery: at the beginning of surgery, immediately after disconnecting the pancreas from the portal vein, just at the moment the pancreatic resection ends and before the skin closed
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1\. Patients older than 18 years, with adenocarcinomas of the pancreas and potentially resectable periampullary tumors by cephalic duodenopancreatectomy or total duodenopancreatectomy indicated intraoperatively for technical reasons, who voluntarily agree to participate in the study and sign informed consent Exclusion Criteria: 1. Patients in whom liver metastases or peritoneal carcinomatosis are detected during surgery. 2. Patients with neuroendocrine pancreatic tumors or cystic tumors. 3. Patients in whom tumor resection is not finally achieved because it shows intraoperatively that the tumor is locally advanced and unresectable. 4. Patients with macroscopic residual tumor (R2). 5. High-risk patients with severe pathology (ASA IV) according to the American Association of Anesthesiologists. 6. Patients receiving neoadjuvant therapy 7. Patients in whom the intraoperative pathological anatomy indicates borders of pancreatic resection affected
References
Publications (19)
- BACKGROUNDMatsuno S, Egawa S, Fukuyama S, Motoi F, Sunamura M, Isaji S, Imaizumi T, Okada S, Kato H, Suda K, Nakao A, Hiraoka T, Hosotani R, Takeda K. Pancreatic Cancer Registry in Japan: 20 years of experience. Pancreas. 2004 Apr;28(3):219-30. doi: 10.1097/00006676-200404000-00002. PMID 15084961
- BACKGROUNDKutomi G, Mizuguchi T, Satomi F, Maeda H, Shima H, Kimura Y, Hirata K. Current status of the prognostic molecular biomarkers in breast cancer: A systematic review. Oncol Lett. 2017 Mar;13(3):1491-1498. doi: 10.3892/ol.2017.5609. Epub 2017 Jan 17. PMID 28454281
- BACKGROUNDJamieson NB, Foulis AK, Oien KA, Going JJ, Glen P, Dickson EJ, Imrie CW, McKay CJ, Carter R. Positive mobilization margins alone do not influence survival following pancreatico-duodenectomy for pancreatic ductal adenocarcinoma. Ann Surg. 2010 Jun;251(6):1003-10. doi: 10.1097/SLA.0b013e3181d77369. PMID 20485150
- BACKGROUNDAlamo JM, Marin LM, Suarez G, Bernal C, Serrano J, Barrera L, Gomez MA, Muntane J, Padillo FJ. Improving outcomes in pancreatic cancer: key points in perioperative management. World J Gastroenterol. 2014 Oct 21;20(39):14237-45. doi: 10.3748/wjg.v20.i39.14237. PMID 25339810
- BACKGROUNDSabater L, Calvete J, Aparisi L, Canovas R, Munoz E, Anon R, Rosello S, Rodriguez E, Camps B, Alfonso R, Sala C, Sastre J, Cervantes A, Lledo S. [Pancreatic and periampullary tumors: morbidity, mortality, functional results and long-term survival]. Cir Esp. 2009 Sep;86(3):159-66. doi: 10.1016/j.ciresp.2009.03.014. Epub 2009 Jul 18. Spanish. PMID 19616203
- BACKGROUNDVerbeke CS, Menon KV. Redefining resection margin status in pancreatic cancer. HPB (Oxford). 2009 Jun;11(4):282-9. doi: 10.1111/j.1477-2574.2009.00055.x. PMID 19718354
- BACKGROUNDEarl J, Garcia-Nieto S, Martinez-Avila JC, Montans J, Sanjuanbenito A, Rodriguez-Garrote M, Lisa E, Mendia E, Lobo E, Malats N, Carrato A, Guillen-Ponce C. Circulating tumor cells (Ctc) and kras mutant circulating free Dna (cfdna) detection in peripheral blood as biomarkers in patients diagnosed with exocrine pancreatic cancer. BMC Cancer. 2015 Oct 24;15:797. doi: 10.1186/s12885-015-1779-7.