Metastasis Clinical Trial
— CETUPANCOfficial title:
Role of Circulating Tumor Cells (CTC´s) Spread During Pancreaticoduodenectomy in Metastasis and Survival Rates in Patients With Pancreatic and Periampullary Tumors
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.
Status | Completed |
Enrollment | 86 |
Est. completion date | July 15, 2023 |
Est. primary completion date | July 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario Virgen del Rocío | Sevilla |
Lead Sponsor | Collaborator |
---|---|
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla |
Spain,
Alamo 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. — View Citation
BARNES JP. Physiologic resection of the right colon. Surg Gynecol Obstet. 1952 Jun;94(6):722-6. No abstract available. — View Citation
Connor AA, McNamara K, Al-Sukhni E, Diskin J, Chan D, Ash C, Lowes LE, Allan AL, Zogopoulos G, Moulton CA, Gallinger S. Central, But Not Peripheral, Circulating Tumor Cells are Prognostic in Patients Undergoing Resection of Colorectal Cancer Liver Metastases. Ann Surg Oncol. 2016 Jul;23(7):2168-75. doi: 10.1245/s10434-015-5038-6. Epub 2015 Dec 29. — View Citation
Earl 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. — View Citation
Gall TM, Jacob J, Frampton AE, Krell J, Kyriakides C, Castellano L, Stebbing J, Jiao LR. Reduced dissemination of circulating tumor cells with no-touch isolation surgical technique in patients with pancreatic cancer. JAMA Surg. 2014 May;149(5):482-5. doi: 10.1001/jamasurg.2013.3643. — View Citation
Hirota M, Kanemitsu K, Takamori H, Chikamoto A, Tanaka H, Sugita H, Sand J, Nordback I, Baba H. Pancreatoduodenectomy using a no-touch isolation technique. Am J Surg. 2010 May;199(5):e65-8. doi: 10.1016/j.amjsurg.2008.06.035. Epub 2008 Dec 18. — View Citation
Hirota M, Ogawa M. No-touch pancreatectomy for invasive ductal carcinoma of the pancreas. JOP. 2014 May 27;15(3):243-9. doi: 10.6092/1590-8577/2502. — View Citation
Jamieson 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. — View Citation
Kobayashi S, Asano T, Ochiai T. A proposal of no-touch isolation technique in pancreatoduodenectomy for periampullary carcinomas. Hepatogastroenterology. 2001 Mar-Apr;48(38):372-4. — View Citation
Kuroki T, Eguchi S. No-touch isolation techniques for pancreatic cancer. Surg Today. 2017 Jan;47(1):8-13. doi: 10.1007/s00595-016-1317-5. Epub 2016 Mar 1. — View Citation
Kutomi 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. — View Citation
Matsuno 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. — View Citation
Pessaux P, Marzano E, Rosso E. A plea for the artery-first dissection during pancreaticoduodenectomy. J Am Coll Surg. 2010 Jul;211(1):142-3. doi: 10.1016/j.jamcollsurg.2010.03.026. No abstract available. — View Citation
Poruk KE, Valero V 3rd, Saunders T, Blackford AL, Griffin JF, Poling J, Hruban RH, Anders RA, Herman J, Zheng L, Rasheed ZA, Laheru DA, Ahuja N, Weiss MJ, Cameron JL, Goggins M, Iacobuzio-Donahue CA, Wood LD, Wolfgang CL. Circulating Tumor Cell Phenotype Predicts Recurrence and Survival in Pancreatic Adenocarcinoma. Ann Surg. 2016 Dec;264(6):1073-1081. doi: 10.1097/SLA.0000000000001600. — View Citation
Sabater 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. — View Citation
Sanjay P, Takaori K, Govil S, Shrikhande SV, Windsor JA. 'Artery-first' approaches to pancreatoduodenectomy. Br J Surg. 2012 Aug;99(8):1027-35. doi: 10.1002/bjs.8763. Epub 2012 May 9. — View Citation
Verbeke 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. — View Citation
Weitz J, Rahbari N, Koch M, Buchler MW. The "artery first" approach for resection of pancreatic head cancer. J Am Coll Surg. 2010 Feb;210(2):e1-4. doi: 10.1016/j.jamcollsurg.2009.10.019. Epub 2009 Dec 3. No abstract available. — View Citation
* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Circulating tumor cells (CTC´s) | Change in the concentration of circulating tumor cells (CTCs) levels (nº CTCs/ mL blood) during the surgery, 4 blood samples will be taken from the portal vein | 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 | |
Primary | Local tumor recurrence | Presence (YES or NO) compatible images of local tumor recurrence Valid imaging tests of presence or absence can be checked by: computerized tomography (CT) or magnetic resonance (NMR) | From the day of surgery to 3 years of follow-up | |
Primary | Metastasis | Presence (YES or NO) compatible images of metastasis | From the day of surgery to 3 years of follow-up | |
Primary | Patient survival | Death (YES OR NO): number of patients dying during study | From the day of surgery to 3 years of follow-up | |
Secondary | Morbidity | The complications evaluation and their severity will be based on the classification of Dindo-Clavien and the definitions of the International Study Group of Pancreatic Surgery (ISGPS).
Pancreatic fistula: Presence (yes or no) and degree (A, B, C) Delayed gastric emptying: Presence (yes or no) and degree (A, B, C) Hemorrhage: Presence (yes or no) and degree (A, B, C) |
From the day of surgery up to 6 weeks of follow-up |
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