The CARDIA-trial protocol: a multinational, prospective, randomized, clinical trial comparing transthoracic esophagectomy with transhiatal extended gastrectomy in adenocarcinoma of the gastroesophageal junction (GEJ) type II

Abstract

Background: Adenocarcinoma of the gastroesophageal junction (GEJ) Siewert type II can be resected by transthoracic esophagectomy or transhiatal extended gastrectomy. Both allow for a complete tumor resection, yet there is an ongoing controversy about which surgical approach is superior with regards to quality of life, oncological outcomes and survival. While some studies suggest a better oncological outcome after transthoracic esophagectomy, others favor transhiatal extended gastrectomy for a better postoperative quality of life. To date, only retrospective studies are available, showing ambiguous results. Methods: This study is a multinational, multicenter, randomized, clinical superiority trial. Patients (n = 262) with a GEJ type II tumor resectable by both transthoracic esophagectomy and transhiatal extended gastrectomy will be enrolled in the trial. Type II tumors are defined as tumors with their midpoint between ≤1 cm proximal and ≤ 2 cm distal of the top of gastric folds on preoperative endoscopy. Patients will be included in one of the participating European sites and are randomized to either transthoracic esophagectomy or transhiatal extended gastrectomy. The trial is powered to show superiority for esophagectomy with regards to the primary efficacy endpoint overall survival. Key secondary endpoints are complete resection (R0), number and localization of tumor infiltrated lymph nodes at dissection, post-operative complications, disease-free survival, quality of life and cost-effectiveness. Postoperative survival and quality of life will be followed-up for 24 months after discharge. Further survival follow-up will be conducted as quarterly phone calls up to 60 months.

Does Circular Stapler Size in Surgical Management of Esophageal Cancer Affect Anastomotic Leak Rate? 4-Year Experience of a European High-Volume Center

“…Treatment of patients with esophageal cancer at our National Center of Excellence follows a standardized protocol in line with national and international guidelines [ 1 , 11 , 12 , 13 ]. Following restaging, usually 4–6 weeks after neoadjuvant therapy, either a standardized Ivor Lewis esophagectomy with reconstruction using a gastric conduit and a high thoracic esophagogastric anastomosis is performed at our institution, or if suitable, patients with an adenocarcinoma of the gastroesophageal junction Siewert Type II are enrolled into the CARDIA trial, which aims to compare the oncological and surgical outcome after transthoracic esophagectomy and transhiatal extended gastrectomy [ 14 , 15 ]. For a transthoracic esophagectomy, a hybrid procedure (abdominal part—laparoscopically/thoracic part—open) depicts the current standard at our institution.…”

Chirurgische Therapie des Ösophaguskarzinoms – neue Technologien, moderne Konzepte

“…Zur Beantwortung dieser Frage wurde von unserer Klinik der CARDIA Trial aufgelegt und die ersten Patienten dieser multizentrischen internationalen Studie wurden rekrutiert. Ziel dieser Studie ist der Vergleich des Gesamtüberlebens nach transthorakaler Ivor-Lewis-Ösophagektomie und transhiatal erweiterter Gastrektomie [27]. In den letzten Jahren wird zur Behandlung des AEG II im Frühstadium in manchen Zentren zudem die sog.…”

A neoadjuvans FLOT-terápia hatása az előrehaladott gyomor-cardia tumorok rövid távú onkológiai és sebészi kezelés eredményeire

“…Ennek megfelelően az ilyen típusú daganatoknál a minél radikálisabb sebészeti eljárásokat szorgalmazták [16]. A két ellentétes tábor megnyilatkozása olvasható a FREGAT-working group, illetve a CARDIA-trial vizsgálati eredményeiben [18,19]. A kérdés az, hogy Siewert II-es típusú elhelyezkedésében az adenocarcinomákat egy transhiatalisan kiterjesztett minimal invazív módón történő total gastrectomiaval operáljuk meg, komplett D2-lymphadenectomát végezve vagy egy distalis nyelőcső resectiót végezzünk, a gyomor felső polusának resectiójával (SPO), csőgyomorképzéssel, többek között mediastinalis lymhadenectomiával, intrathoracalis anastomosissal [20,21].…”