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

NCT04597398 | Completed

• 1 other identifier: ShizuokaCC
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Keywords

Esophageal reconstructive surgery, Remnant esophagus,

Outcome Measures

Primary Outcomes (1)

• anastomosis leakage

  the rate of anastomosis leakage between remnant esophagus and pedicled jejunum

  1months after surgery

Study Arms (2)

Group A

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

Group B

11 patients underwent the procedure as of June 2019

Device: Evaluation of blood flow with indocyanine green

Interventions

Evaluation of blood flow with indocyanine green DEVICE

Group B

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Between January 2011 and June 2020, 50 patients underwent esophagectomy with pedicled jejunum reconstruction at our institute. The patients underwent subtotal esophagectomy via right thoracotomy with either an endoscopic or open procedure.

You may qualify if:

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

You may not qualify if:

• patients who did not complete the esophagectomy

Sponsors & Collaborators

• Shizuoka Cancer Center: lead

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 22, 2020
• Study Start: April 1, 2012
• Primary Completion: June 30, 2020
• Study Completion: July 30, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share