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

Esophagectomy Clinical Trial

Official title:

Utility of the Evaluation of Blood Flow With Indocyanine Green in Setting the Anastomosis Site of the Remnant Esophagus in Esophagectomy With Pedicled Jejunum Reconstruction: A Case Series

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04597398
• Other study ID #: ShizuokaCC
• Status: Completed
• Start date: April 1, 2012
• Est. completion date: July 30, 2020

Study information

• Verified date: October 2020
• Source: Shizuoka Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Esophagectomy

Intervention

Device:
• Evaluation of blood flow with indocyanine green

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shizuoka Cancer Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anastomosis leakage	the rate of anastomosis leakage between remnant esophagus and pedicled jejunum	1months after surgery