Endoscopic Evaluation for Predicting the Complications Related to Gastric Conduit After Esophagectomy

NCT02937389 | Completed

• 1 other identifier: 16082202
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Gastric conduit ischemia or anastomotic breakdown after esophagectomy with cervical esophagogastrostomy often cause severe complications, such as leakage, necrotic organs, and strictures. Thus, the purpose of this study is the safety and efficacy of endoscopic evaluation about reconstructive organs after esophagectomy. The investigators evaluate endoscopic predictions using classifications in acute phase after esophagogastrostomy.

Conditions

Esophageal Neoplasms; Constriction; Anastomotic Leak; Ischemia

Outcome Measures

Primary Outcomes (1)

• The classification of gastric conduit ischemia by endoscopic findings predicts the major complications of gastric conduit (strictures, leakage, necrosis)

  From 1 to 29 days after esophagectomy

Secondary Outcomes (3)

• Biological examination of the mucosal biopsy of gastric conduit as assessed by the ischemia related RNA copy number

  From 1 to 15 days after esophagectomy

• Biological examination of the mucosal biopsy of gastric conduit as assessed by the scoring system for immunohistochemical staining

  From 1 to 15 days after esophagectomy

• Biological examination of gastric conduit as assessed by the Mitochondrial DNA copy number

  From 1 to 15 days after esophagectomy

Interventions

Patients after esophagectomy DIAGNOSTIC_TEST

Endoscopic examinations are performed at 1 and 8 postoperative days. Endoscopic examination is added when abnormal findings are demonstrated.

Eligibility Criteria

• Age: 20 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergo an esophagectomy with reconstruction by a gastric pull-up for malignant or end-stage benign esophageal disease. The patients have a cervical esophagogastrostomy.

You may qualify if:

• \- Malignant or end-stage benign esophageal disease. Esophagectomy with reconstruction by a gastric pull-up.

You may not qualify if:

• \- Severe heart failure and pulmonary dysfunction Severe renal and liver dysfunction Allergenic history Pregnancy

Sponsors & Collaborators

• Nagasaki University: lead

Study Sites (1)

Nagasaki University Hospital

Nagasaki, 852-8501, Japan

Location

Related Publications (1)

• Kobayashi S, Kanetaka K, Yoneda A, Yamaguchi N, Kobayashi K, Nagata Y, Maruya Y, Yamaguchi S, Hidaka M, Eguchi S. Endoscopic mucosal ischemic index for predicting anastomotic complications after esophagectomy: a prospective cohort study. Langenbecks Arch Surg. 2023 Jan 17;408(1):37. doi: 10.1007/s00423-023-02783-x.

  PMID: 36648542 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

dmpDNA

MeSH Terms

Conditions

Esophageal Neoplasms; Constriction, Pathologic; Anastomotic Leak; Ischemia

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Shinichhiro Kobayashi, M.D.

  Nagasaki University Graduate School of Biomedical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator in department of Surgery

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 18, 2016
• Study Start: May 1, 2015
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2019
• Last Updated: April 5, 2023

Record last verified: 2023-04

Locations

JP (1)