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OpenTrials
Completed

NCT Number: NCT04597398

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

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluation of blood flow with indocyanine green

Device

Primary outcomes

  1. anastomosis leakage

    Time frame: 1months after surgery

    the rate of anastomosis leakage between remnant esophagus and pedicled jejunum

Sponsors and collaborators

Lead sponsor

Shizuoka Cancer Center

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Oct 22, 2020
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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