Trial on Delay Phenomenon Utility in Preventing Anastomotic Leakage After an Esophagectomy

NCT02432794 | Completed DMC

• 1 other identifier: APIL_2013
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized clinical trial to clarify if the delay phenomenon could reduce the incidence of oesophagogastric dehiscence after an esophagectomy for esophageal cancer comparing an experimental group vs control group. The delay phenomenon will be performed by an arteriographic approach.

Conditions

Esophageal Anastomotic Leak

Outcome Measures

Primary Outcomes (1)

• Anastomotic leakage

  investigators will consider anastomotic dehiscence the presence of one or more of the following conditions: radiologic confirmation by water-soluble contrast study (gastrografin administered orally) or thoracoabdominal Tc with oral contrast of dehiscence of oesophagogastric anastomosis or the stapler end of the gastroplasty. When the clinical conditions of patient don't allow a Rx control investigators will consider an anastomotic leakage in these conditions: Thoracic drain output of oesophagogastric content with amylase \> 40 ukAT/L, confirmation of anastomotic dehiscence by the surgeon during a reintervention, endoscopic confirmation of anastomotic leakage of the stapled end of the plasty and methylene blue output after oral administration (100 ml of water with 10ml of methylene blue)

  7 days

Secondary Outcomes (6)

• plasty ischemia

  7 days

• hospital stay

  90 days

• major and minor morbidity

  90 days

• postoperative mortality

  during hospitalization and/or 30 days after surgery

• post-embolization morbidity

  30 days

Study Arms (2)

delay phenomenon by arteriography

EXPERIMENTAL

intervention: delay phenomenon by arteriography. Patients who will be subjected a delay phenomenon by arteriographic procedure before esophageal resection surgery minimum 14 days before surgery. An angiogram of the celiac trunk is performed through a femoral access before and after the embolization. A 4-5 Fr Simmons or Cobra catheter is used for the catheterization and embolization of the left gastric artery, and 0.035-inch platinum coils are proximally placed from the main trunk in the splenic artery. When accessory left gastric arteries are present, they are catheterized and embolized as well. The right gastric artery catheterization is realized by a 4-5 Fr catheter and coils or microcoils are proximally placed in the artery as well.

Procedure: delay phenomenon by arteriographic approach

control group

NO INTERVENTION

Patients who will be operated directly without gastric ischemic conditioning. The investigators don't performed any arteriography before the esophageal surgical resection

Interventions

delay phenomenon by arteriographic approach PROCEDURE

we improve the microvascularization of the gastric fundus occluding the right and left gastric artery, and splenic artery two weeks before surgery by arteriography

delay phenomenon by arteriography

Eligibility Criteria

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

You may qualify if:

• All patients requiring a subtotal esophagectomy with en-bloc resection and an intrathoracic esophagogastrostomy for esophageal cancer
• or above years old
• Acceptance and signing the full informed consent

You may not qualify if:

• Absence of pancreatitis
• Anatomic vascular alteration that contraindicate the embolization (congenital celiac trunk stenosis, presence of arcuate ligament,etc,..)
• refuse to collaborate in the study

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (1)

Leandre Farran Teixidor

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (15)

• Gonzalez-Gonzalez JJ, Sanz-Alvarez L, Marques-Alvarez L, Navarrete-Guijosa F, Martinez-Rodriguez E. [Complications of surgical resection of esophageal cancer]. Cir Esp. 2006 Dec;80(6):349-60. doi: 10.1016/s0009-739x(06)70987-3. Spanish.

  PMID: 17192218 RESULT

• Schroder W, Beckurts KT, Stahler D, Stutzer H, Fischer JH, Holscher AH. Microcirculatory changes associated with gastric tube formation in the pig. Eur Surg Res. 2002 Nov-Dec;34(6):411-7. doi: 10.1159/000065709.

  PMID: 12403940 RESULT

• Farran Teixidor L, Llop Talaveron J, Galan Guzman M, Aranda Danso H, Miro Martin M, Bettonica Larranaga C, Estremiana Garcia F, Biondo S. [Surgical outcomes of esophageal cancer resection since the development of an Oesophagogastric Tumour Board]. Cir Esp. 2013 Oct;91(8):517-23. doi: 10.1016/j.ciresp.2012.12.005. Epub 2013 Apr 11. Spanish.

  PMID: 23583091 RESULT

• Patil PK, Patel SG, Mistry RC, Deshpande RK, Desai PB. Cancer of the esophagus: esophagogastric anastomotic leak--a retrospective study of predisposing factors. J Surg Oncol. 1992 Mar;49(3):163-7. doi: 10.1002/jso.2930490307.

  PMID: 1548890 RESULT

• Griffin SM, Shaw IH, Dresner SM. Early complications after Ivor Lewis subtotal esophagectomy with two-field lymphadenectomy: risk factors and management. J Am Coll Surg. 2002 Mar;194(3):285-97. doi: 10.1016/s1072-7515(01)01177-2.

  PMID: 11893132 RESULT

• Schroder W, Holscher AH, Bludau M, Vallbohmer D, Bollschweiler E, Gutschow C. Ivor-Lewis esophagectomy with and without laparoscopic conditioning of the gastric conduit. World J Surg. 2010 Apr;34(4):738-43. doi: 10.1007/s00268-010-0403-x.

  PMID: 20098986 RESULT

• Metzger R, Bollschweiler E, Vallbohmer D, Maish M, DeMeester TR, Holscher AH. High volume centers for esophagectomy: what is the number needed to achieve low postoperative mortality? Dis Esophagus. 2004;17(4):310-4. doi: 10.1111/j.1442-2050.2004.00431.x.

  PMID: 15569369 RESULT

• Liebermann-Meffert DM, Meier R, Siewert JR. Vascular anatomy of the gastric tube used for esophageal reconstruction. Ann Thorac Surg. 1992 Dec;54(6):1110-5. doi: 10.1016/0003-4975(92)90077-h.

  PMID: 1449294 RESULT

• Boyle NH, Pearce A, Hunter D, Owen WJ, Mason RC. Scanning laser Doppler flowmetry and intraluminal recirculating gas tonometry in the assessment of gastric and jejunal perfusion during oesophageal resection. Br J Surg. 1998 Oct;85(10):1407-11. doi: 10.1046/j.1365-2168.1998.00943.x.

  PMID: 9782026 RESULT

• Urschel JD. Ischemic conditioning of the rat stomach: implications for esophageal replacement with stomach. J Cardiovasc Surg (Torino). 1995 Apr;36(2):191-3.

  PMID: 7790342 RESULT

• Yuan Y, Duranceau A, Ferraro P, Martin J, Liberman M. Vascular conditioning of the stomach before esophageal reconstruction by gastric interposition. Dis Esophagus. 2012 Nov-Dec;25(8):740-9. doi: 10.1111/j.1442-2050.2011.01311.x. Epub 2012 Jan 31.

  PMID: 22292613 RESULT

• Akiyama S, Kodera Y, Sekiguchi H, Kasai Y, Kondo K, Ito K, Takagi H. Preoperative embolization therapy for esophageal operation. J Surg Oncol. 1998 Dec;69(4):219-23. doi: 10.1002/(sici)1096-9098(199812)69:43.0.co;2-7.

  PMID: 9881938 RESULT

• Isomura T, Itoh S, Endo T, Akiyama S, Maruyama K, Ishiguchi T, Ishigaki T, Takagi H. Efficacy of gastric blood supply redistribution by transarterial embolization: preoperative procedure to prevent postoperative anastomotic leaks following esophagoplasty for esophageal carcinoma. Cardiovasc Intervent Radiol. 1999 Mar-Apr;22(2):119-23. doi: 10.1007/s002709900346.

  PMID: 10094991 RESULT

• Lamas S, Azuara D, de Oca J, Sans M, Farran L, Alba E, Escalante E, Rafecas A. Time course of necrosis/apoptosis and neovascularization during experimental gastric conditioning. Dis Esophagus. 2008;21(4):370-6. doi: 10.1111/j.1442-2050.2007.00772.x.

  PMID: 18477261 RESULT

• Farran L, Miro M, Alba E, Bettonica C, Aranda H, Galan M, Rafecas A. Preoperative gastric conditioning in cervical gastroplasty. Dis Esophagus. 2011 May;24(4):205-10. doi: 10.1111/j.1442-2050.2010.01115.x. Epub 2010 Oct 11.

  PMID: 21040153 RESULT

Study Officials

• Leandre F Teixidor, Ph D, MD

  Bellvitge University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of oesophagogastric surgery department

Study Record Dates

• First Submitted: April 21, 2015
• First Posted: May 4, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2019
• Study Completion: June 1, 2019
• Last Updated: August 20, 2019

Record last verified: 2019-08

Locations

ES (1)