A Prospective Observational Study on Characteristic Endoscopic Findings in Anastomotic Leakage after Esophagectomy

A Prospective Observational Study on Characteristic Endoscopic Findings in Anastomotic Leakage after Esophagectomy - A Observational Study on Characteristic Endoscopic Findings in Anastomotic Leakage after Esophagectomy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000054597

Enrollment

180

Registered

2024-06-06

Start date

2024-06-06

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Men and women aged 20-85 diagnosed with cervical and thoracic esophageal cancer or esophagogastric junction cancer. (2) Clinical Stage I-IVA (UICC TNM Classification 8th edition), excluding T4b. (3) Cases undergoing thoracoscopic esophagectomy (including robot-assisted) with reconstruction using a gastric tube through the posterior mediastinal or retrosternal route, at Tohoku University Hospital, Department of General Surgery (Esophageal Surgery Group) from May 2024 to March 2026. (4) Individuals who have provided written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: For effectiveness evaluation: 1. Cases reconstructed using the small intestine or colon, and cases reconstructed via the anterior thoracic route. For safety evaluation: 2. Patients with allergies to medications used during endoscopic examination (e.g., Xylocaine spray, midazolam, flumazenil). 3. Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding. From the perspective of risk/benefit balance: 4. Patients with a history of clinically significant mental disorders or central nervous system disorders. 5. Patients deemed unsuitable for this study by the responsible (or participating) physician.

Design outcomes

Primary

Measure	Time frame
Presence of anastomotic leakage Definition of anastomotic leakage in this study: Cases where a fistula is endoscopically confirmed at the anastomotic site, and classified as Clavien-Dindo Grade II (requiring pharmacological therapy with antibiotics) or higher. Presence of mucosal defect Definition of mucosal defect in this study: Cases where a mucosal defect is endoscopically observed at the anastomotic site but does not meet the definition of anastomotic leakage.	—

Measure

Time frame

Presence of anastomotic leakage Definition of anastomotic leakage in this study: Cases where a fistula is endoscopically confirmed at the anastomotic site, and classified as Clavien-Dindo Grade II (requiring pharmacological therapy with antibiotics) or higher. Presence of mucosal defect Definition of mucosal defect in this study: Cases where a mucosal defect is endoscopically observed at the anastomotic site but does not meet the definition of anastomotic leakage.

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Countries

Japan

Contacts

Public ContactHirotaka Ishida

Tohoku University Graduate School of Medicine Department of Surgery

h-ishida@tohoku.ac.jp+81-227177214

Outcome results