Pilot Trial on Ischemic Conditioning of the Gastric Conduit in Esophageal Cancer: Feasibility and Impact on Anastomotic Leakage (TIGOAL-I)
Objective:. To evaluate the feasibility, safety, and effectiveness of gastric conditioning using preoperative arterial embolization (PAE) before McKeown esophagectomy at a tertiary university hospital. Background:. Cervical anastomotic leakage (AL) is a common complication of esophagectomy. Limited...
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| Format: | Article |
| Language: | English |
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Wolters Kluwer Health
2024-03-01
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| Series: | Annals of Surgery Open |
| Online Access: | http://journals.lww.com/10.1097/AS9.0000000000000379 |
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| author | María-Carmen Fernández-Moreno, MD, PhD María Eugenia Barrios Carvajal, MD Fernando López Mozos, MD, PhD Roberto Martí Obiol, MD, PhD Jorge Guijarro Rozalén, MD, PhD Elisabetta Casula, MD, PhD Joaquín Ortega, MD, PhD |
| author_facet | María-Carmen Fernández-Moreno, MD, PhD María Eugenia Barrios Carvajal, MD Fernando López Mozos, MD, PhD Roberto Martí Obiol, MD, PhD Jorge Guijarro Rozalén, MD, PhD Elisabetta Casula, MD, PhD Joaquín Ortega, MD, PhD |
| author_sort | María-Carmen Fernández-Moreno, MD, PhD |
| collection | DOAJ |
| description | Objective:. To evaluate the feasibility, safety, and effectiveness of gastric conditioning using preoperative arterial embolization (PAE) before McKeown esophagectomy at a tertiary university hospital.
Background:. Cervical anastomotic leakage (AL) is a common complication of esophagectomy. Limited clinical evidence suggests that gastric conditioning mitigates this risk.
Methods:. This pilot randomized clinical trial was conducted between April 2016 and October 2021 at a single-center tertiary hospital. Eligible patients with resectable malignant esophageal tumors, suitable for cervical esophagogastrostomy, were randomized into 2 groups: one receiving PAE and the other standard treatment. The primary endpoints were PAE-related complications and incidence of cervical AL.
Results:. The study enrolled 40 eligible patients. PAE-related morbidity was 10%, with no Clavien-Dindo grade III complications. Cervical AL rates were similar between the groups (35% vs 25%, P = 0.49), even when conduit necrosis was included (35% vs 35%, P = 1). However, AL severity, including conduit necrosis, was higher in the control group according to the Clavien-Dindo ≥IIIb (5% vs 30%, P = 0.029) and Comprehensive Complication Index (20.9 vs 33.7, P = 0.01). No significant differences were found in other postoperative complications, such as pneumonia or postoperative mortality.
Conclusions:. PAE is a feasible and safe method for gastric conditioning before McKeown minimally invasive esophagectomy and shows promise for preventing severe AL. However, further studies are required to confirm its efficacy. |
| format | Article |
| id | doaj-art-0d838aed812a4564a4fe8ba229089eab |
| institution | Kabale University |
| issn | 2691-3593 |
| language | English |
| publishDate | 2024-03-01 |
| publisher | Wolters Kluwer Health |
| record_format | Article |
| series | Annals of Surgery Open |
| spelling | doaj-art-0d838aed812a4564a4fe8ba229089eab2025-01-24T09:18:25ZengWolters Kluwer HealthAnnals of Surgery Open2691-35932024-03-0151e37910.1097/AS9.0000000000000379202403000-00014Pilot Trial on Ischemic Conditioning of the Gastric Conduit in Esophageal Cancer: Feasibility and Impact on Anastomotic Leakage (TIGOAL-I)María-Carmen Fernández-Moreno, MD, PhD0María Eugenia Barrios Carvajal, MD1Fernando López Mozos, MD, PhD2Roberto Martí Obiol, MD, PhD3Jorge Guijarro Rozalén, MD, PhD4Elisabetta Casula, MD, PhD5Joaquín Ortega, MD, PhD6From the * Department of Surgery, Esophagogastric Surgery Unit, Biomedical Research Institute INCLIVA, University Clinic Hospital of Valencia, SpainFrom the * Department of Surgery, Esophagogastric Surgery Unit, Biomedical Research Institute INCLIVA, University Clinic Hospital of Valencia, SpainFrom the * Department of Surgery, Esophagogastric Surgery Unit, Biomedical Research Institute INCLIVA, University Clinic Hospital of Valencia, SpainFrom the * Department of Surgery, Esophagogastric Surgery Unit, Biomedical Research Institute INCLIVA, University Clinic Hospital of Valencia, Spain† Department of Interventional Radiology. University Clinic Hospital of Valencia, Spain† Department of Interventional Radiology. University Clinic Hospital of Valencia, SpainFrom the * Department of Surgery, Esophagogastric Surgery Unit, Biomedical Research Institute INCLIVA, University Clinic Hospital of Valencia, SpainObjective:. To evaluate the feasibility, safety, and effectiveness of gastric conditioning using preoperative arterial embolization (PAE) before McKeown esophagectomy at a tertiary university hospital. Background:. Cervical anastomotic leakage (AL) is a common complication of esophagectomy. Limited clinical evidence suggests that gastric conditioning mitigates this risk. Methods:. This pilot randomized clinical trial was conducted between April 2016 and October 2021 at a single-center tertiary hospital. Eligible patients with resectable malignant esophageal tumors, suitable for cervical esophagogastrostomy, were randomized into 2 groups: one receiving PAE and the other standard treatment. The primary endpoints were PAE-related complications and incidence of cervical AL. Results:. The study enrolled 40 eligible patients. PAE-related morbidity was 10%, with no Clavien-Dindo grade III complications. Cervical AL rates were similar between the groups (35% vs 25%, P = 0.49), even when conduit necrosis was included (35% vs 35%, P = 1). However, AL severity, including conduit necrosis, was higher in the control group according to the Clavien-Dindo ≥IIIb (5% vs 30%, P = 0.029) and Comprehensive Complication Index (20.9 vs 33.7, P = 0.01). No significant differences were found in other postoperative complications, such as pneumonia or postoperative mortality. Conclusions:. PAE is a feasible and safe method for gastric conditioning before McKeown minimally invasive esophagectomy and shows promise for preventing severe AL. However, further studies are required to confirm its efficacy.http://journals.lww.com/10.1097/AS9.0000000000000379 |
| spellingShingle | María-Carmen Fernández-Moreno, MD, PhD María Eugenia Barrios Carvajal, MD Fernando López Mozos, MD, PhD Roberto Martí Obiol, MD, PhD Jorge Guijarro Rozalén, MD, PhD Elisabetta Casula, MD, PhD Joaquín Ortega, MD, PhD Pilot Trial on Ischemic Conditioning of the Gastric Conduit in Esophageal Cancer: Feasibility and Impact on Anastomotic Leakage (TIGOAL-I) Annals of Surgery Open |
| title | Pilot Trial on Ischemic Conditioning of the Gastric Conduit in Esophageal Cancer: Feasibility and Impact on Anastomotic Leakage (TIGOAL-I) |
| title_full | Pilot Trial on Ischemic Conditioning of the Gastric Conduit in Esophageal Cancer: Feasibility and Impact on Anastomotic Leakage (TIGOAL-I) |
| title_fullStr | Pilot Trial on Ischemic Conditioning of the Gastric Conduit in Esophageal Cancer: Feasibility and Impact on Anastomotic Leakage (TIGOAL-I) |
| title_full_unstemmed | Pilot Trial on Ischemic Conditioning of the Gastric Conduit in Esophageal Cancer: Feasibility and Impact on Anastomotic Leakage (TIGOAL-I) |
| title_short | Pilot Trial on Ischemic Conditioning of the Gastric Conduit in Esophageal Cancer: Feasibility and Impact on Anastomotic Leakage (TIGOAL-I) |
| title_sort | pilot trial on ischemic conditioning of the gastric conduit in esophageal cancer feasibility and impact on anastomotic leakage tigoal i |
| url | http://journals.lww.com/10.1097/AS9.0000000000000379 |
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