Role of CTC´s Spread During Pancreaticoduodenectomy in Patients With Pancreatic and Periampullary Tumors

NCT03340844 | Completed

• 1 other identifier: CETUPANC
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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

Pancreatic Tumor; Periampullary Carcinoma Resectable; Circulating Tumor Cells; Metastasis

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Metastasis

  Presence (YES or NO) compatible images of metastasis

  From the day of surgery to 3 years of follow-up

• Patient survival

  Death (YES OR NO): number of patients dying during study

  From the day of surgery to 3 years of follow-up

Secondary Outcomes (1)

• Morbidity

  From the day of surgery up to 6 weeks of follow-up

Study Arms (2)

No Touch (NT)

EXPERIMENTAL

Pancreatic and Periampullary Tumors resection by no-touch technique

Procedure: No Touch (NT)

Superior Mesenteric Artery First (SMA)

ACTIVE COMPARATOR

Pancreatic and Periampullary Tumors resection by superior Mesenteric Artery First technique

Procedure: Superior Mesenteric Artery First (SMA)

Interventions

No Touch (NT) PROCEDURE

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.

No Touch (NT)

Superior Mesenteric Artery First (SMA) PROCEDURE

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).

Superior Mesenteric Artery First (SMA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• Patients in whom liver metastases or peritoneal carcinomatosis are detected during surgery.
• Patients with neuroendocrine pancreatic tumors or cystic tumors.
• Patients in whom tumor resection is not finally achieved because it shows intraoperatively that the tumor is locally advanced and unresectable.
• Patients with macroscopic residual tumor (R2).
• High-risk patients with severe pathology (ASA IV) according to the American Association of Anesthesiologists.
• Patients receiving neoadjuvant therapy
• Patients in whom the intraoperative pathological anatomy indicates borders of pancreatic resection affected

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (1)

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Related Publications (19)

• 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.

  PMID: 15084961 BACKGROUND

• 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.

  PMID: 28454281 BACKGROUND

• 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.

  PMID: 20485150 BACKGROUND

• 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.

  PMID: 25339810 BACKGROUND

• 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.

  PMID: 19616203 BACKGROUND

• 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.

  PMID: 19718354 BACKGROUND

• 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.

  PMID: 26498594 BACKGROUND

• 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.

  PMID: 26714949 BACKGROUND

• 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.

  PMID: 26756760 BACKGROUND

• BARNES JP. Physiologic resection of the right colon. Surg Gynecol Obstet. 1952 Jun;94(6):722-6. No abstract available.

  PMID: 14931182 BACKGROUND

• 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.

  PMID: 19095210 BACKGROUND

• 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.

  PMID: 24865535 BACKGROUND

• 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.

  PMID: 11379311 BACKGROUND

• 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.

  PMID: 24599353 BACKGROUND

• 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.

  PMID: 20610264 BACKGROUND

• 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.

  PMID: 20113929 BACKGROUND

• 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.

  PMID: 22569924 BACKGROUND

• 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.

  PMID: 26931548 BACKGROUND

• 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.

  PMID: 39485887 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplastic Cells, Circulating; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Francisco Javier Padillo Ruiz, PhD

  Hospitales Universitarios Virgen del Rocío

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized (1:1) to 2 study groups according to duodenopancreatectomy surgical approach: "No-Touch group" (NT) or "Artery First group" (SMA) in patients with pancreatic and periampullary tumors, to evaluated circulating tumor cells (CTCs) levels during the surgery. Sample size = 86

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: November 14, 2017
• Study Start: December 15, 2017
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: May 14, 2024

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Within 6 months after database closure and analysis.

Locations

ES (1)