Tokyo, Nov. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059651) titled 'A multicenter retrospective observational study on the impact of non-GAstric conduit ReconstruCtion ON postoperative outcomes after ESOphagectomy (ESO-GARCON Study)' on Nov. 5.
Study Type:
Observational
Primary Sponsor:
Institute - Gifu University
Condition:
Condition - esophageal cancer, esophagogastric junction cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To clarify the impact of non-gastric conduit reconstruction on postoperative outcomes after esophagectomy, this study aims to identify the optimal reconstruction method for non-gastric conduit cases and to compare both short- and long-term outcomes, including nutritional indicators, between colonic and jejunal reconstructions.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients who meet any of the following criteria will be included:
Patients with cervical, thoracic, or abdominal esophageal cancer, or esophagogastric junction cancer, who have a history of gastrectomy (regardless of whether the previous gastrectomy was for benign or malignant disease) and underwent curative resection with non-gastric conduit reconstruction (using colon or small intestine), either as a one-stage or staged procedure.
Patients with esophagogastric junction cancer requiring total esophagectomy and gastrectomy (or proximal gastrectomy) who underwent curative resection with non-gastric conduit reconstruction (using colon or small intestine), either as a one-stage or staged procedure.
Patients with double cancer involving the cervical, thoracic, or abdominal esophagus and stomach, requiring total esophagectomy and gastrectomy (or proximal gastrectomy), who underwent curative resection with non-gastric conduit reconstruction (using colon or small intestine), either as a one-stage or staged procedure. Cases of esophageal cancer with gastric invasion and gastric cancer with esophageal invasion will be handled in the same manner.
Patients who underwent curative resection with non-gastric conduit reconstruction (using colon or small intestine), either as a one-stage or staged procedure, due to intraoperative complications (e.g., intraoperative gastric conduit necrosis).
Among the above, eligible patients are those aged 18 years or older who underwent surgery between January 1, 2013, and December 31, 2023.
Key exclusion criteria - Patients who underwent non-gastric conduit reconstruction as a reoperation due to postoperative complications (e.g., anastomotic leakage, gastric conduit necrosis, tracheal fistula, or refractory reflux esophagitis).
Patients who underwent non-gastric conduit reconstruction following curative resection due to local recurrence of a prior disease or other related conditions.
Patients who underwent non-gastric conduit reconstruction for metachronous double cancer, such as gastric conduit cancer.
Patients who declined participation in this study through the optout process.
Patients deemed inappropriate for inclusion by the attending physician's judgment.
Target Size - 300
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 05 Day
Anticipated trial start date - 2025 Year 11 Month 10 Day
Last follow-up date - 2028 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068233
Disclaimer: Curated by HT Syndication.