Utility of the Evaluation of Blood Flow of the Remnant Esophagus in Esophagectomy With Pedicled Jejunum Reconstruction

NCT ID: NCT04597398

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-04-01
• Study Completion Date: 2020-07-30

Brief Summary

Pedicled jejunal flap can be utilized with various tips for esophageal reconstruction in patients with a history of gastrectomy, or those who have undergone synchronous esophagogastrectomy, although the rate of anastomosis leakage is high with this technique. Therefore, in the current study, we considered the utility of the evaluation of blood flow of the remnant esophagus with indocyanine green in setting the anastomosis site. We included 50 patients who underwent radical esophagectomy with pedicled jejunal flap between April 2012 and June 2020. From June 2019, the blood flow of not only the pedicled jejunum, but also the remnant esophagus were evaluated in order to set the anastomosis site of the latter because the color was not definitive criteria for judging in surgery on the remnant esophagus. Usually, the second and third jejunal vessels are transected, and if the jejunal flap cannot reach to the anastomosis point, we actively transect the marginal vessels in order to stretch the jejunal flap. Microvascular anastomosis between the jejunal branches (the second) and the internal thoracic vessels is usually made, and the anastomosis site is set at the part of the esophagus that is well-dyed with indocyanine green. A total of 39 patients underwent the procedure prior to June 2019 ( Group A), and 11 patients underwent the procedure as of June 2019 (Group B). No significant difference was found in the patients' background, type of preoperative therapy, and presence or absence of ligation of marginal vessels and two-stage operation between the two groups. Group A had 16 cases of anastomosis leakage, while Group B only has one (P < 0.05). There were no cases of significant pedicled jejunum graft necrosis. Our findings demonstrate that the evaluation of the blood flow of the remnant esophagus during setting of the anastomosis site may decrease the rate of anastomosis.

Conditions

Esophagectomy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Group A

A total of 39 patients underwent the procedure prior to June 2019

No interventions assigned to this group

Group B

11 patients underwent the procedure as of June 2019

Evaluation of blood flow with indocyanine green

Intervention Type: DEVICE

Interventions

Evaluation of blood flow with indocyanine green

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• patients who underwent radical esophagectomy with pedicled jejunal flap between April 2012 and June 2020

Exclusion Criteria

• patients who did not complete the esophagectomy

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shizuoka Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Kenjiro Ishii

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ShizuokaCC

Identifier Type: -

Identifier Source: org_study_id