Role of CTC´s Spread During Pancreaticoduodenectomy in Patients With Pancreatic and Periampullary Tumors
NCT ID: NCT03340844
Last Updated: 2024-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
86 participants
INTERVENTIONAL
2017-12-15
2023-07-15
Brief Summary
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Detailed Description
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There are different technical variants, it is not standardized what is the best option in relation to local recurrence, metastasis and survival.
In the study, patients will be randomized into two study groups with pancreatic and periampullary tumors undergoing cephalic pancreatectomy (NT) vs initial approach by superior mesenteric artery (SMA).
The measurement of circulating tumor cells (CTCs) allows to assess the degree of cellular dissemination due to surgical manipulation.CTCs will be evaluated during surgery (nº CTCs / mL blood). To do this, a maximum of 4 blood samples from the portal vein will be performed, in each study group according to the following scheme:
* NT group: basal (at the beginning of surgery), portal vein pancreatic detachment, postresection (NT2) and before closure (NT3).
* SMA group: basal (at the beginning of surgery), after Kocher maneuver and SMA dissection, postresection, before closure.
Subsequently, the quantified levels of CTCs will be correlated with the occurrence of local tumor recurrence, metastasis development and patient patient survival.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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No Touch (NT)
Pancreatic and Periampullary Tumors resection by no-touch technique
No Touch (NT)
Tumor resection by No-touch technique: dissection of hepatic hilum, dissection of superior mesenteric vein (SMV) in caudal aspect of pancreas, section of antrum, pancreatic neck section. Section-ligation of veins of duodenopancreatectomy part of SMV and portal. Then Kocher-uncrossing maneuver of the jejunal loop and final section of the retro-portal (back of the portal vein) blade.
Superior Mesenteric Artery First (SMA)
Pancreatic and Periampullary Tumors resection by superior Mesenteric Artery First technique
Superior Mesenteric Artery First (SMA)
Tumor resection by SMA technique: Kocher maneuver extends to the left renal vein (LRV). Dissection above the LRV of the SMA (refer to vessel-loop). Then, SMA will be identified on the caudal side of the pancreas (mesenterial root) and progressive dissection until its origin in the aorta artery (previously referenced with vessel loop).
Interventions
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No Touch (NT)
Tumor resection by No-touch technique: dissection of hepatic hilum, dissection of superior mesenteric vein (SMV) in caudal aspect of pancreas, section of antrum, pancreatic neck section. Section-ligation of veins of duodenopancreatectomy part of SMV and portal. Then Kocher-uncrossing maneuver of the jejunal loop and final section of the retro-portal (back of the portal vein) blade.
Superior Mesenteric Artery First (SMA)
Tumor resection by SMA technique: Kocher maneuver extends to the left renal vein (LRV). Dissection above the LRV of the SMA (refer to vessel-loop). Then, SMA will be identified on the caudal side of the pancreas (mesenterial root) and progressive dissection until its origin in the aorta artery (previously referenced with vessel loop).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
OTHER
Responsible Party
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Principal Investigators
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Francisco Javier Padillo Ruiz, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospitales Universitarios Virgen del Rocío
Locations
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Hospital Universitario Virgen del Rocío
Seville, , Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
BARNES JP. Physiologic resection of the right colon. Surg Gynecol Obstet. 1952 Jun;94(6):722-6. No abstract available.
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.
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.
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.
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.
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.
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.
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.
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.
Padillo-Ruiz J, Fresno C, Suarez G, Blanco G, Munoz-Bellvis L, Justo I, Garcia-Domingo MI, Ausania F, Munoz-Forner E, Serrablo A, Martin E, Diez L, Cepeda C, Marin L, Alamo J, Bernal C, Pereira S, Calero F, Tinoco J, Paterna S, Cugat E, Fondevila C, Diego-Alonso E, Lopez-Guerra D, Gomez M, Denninghoff V, Sabater L. Effects of the superior mesenteric artery approach versus the no-touch approach during pancreatoduodenectomy on the mobilization of circulating tumour cells and clusters in pancreatic cancer (CETUPANC): randomized clinical trial. BJS Open. 2024 Oct 29;8(6):zrae123. doi: 10.1093/bjsopen/zrae123.
Other Identifiers
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CETUPANC
Identifier Type: -
Identifier Source: org_study_id
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