Quantitative Fluorescent Guided Robotic Surgery for Cancer of the Gastroesophageal Junction

NCT04107623 | Completed DMC

• 1 other identifier: H-19041735
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators also aim to use our previously described quantifying method (q-ICG), to evaluate changes in gastric perfusion, during resection of cancer in the gastroesophageal junction (GEJ) and if a change in the operative technique influences microvascular flow in the gastroesophageal (GE) anastomosis.

Conditions

Stomach Neoplasms; Surgery

Keywords

Gastric Conduit; Cardia resection; Indocyanine Green; quantative perfusion

Outcome Measures

Primary Outcomes (1)

• perfusion assessment

  The primary endpoint is the difference in conduit- and anastomotic perfusion between the two groups. The perfusion will be measured intraoperativly using q-ICG.

  The perfussion assesment takes 3-5min.

Secondary Outcomes (8)

• Lymph node resektion

  Caculated after the return of pathology report. The patients will be followed 30 days after surgery

• short term surgical outcome

  Patients will be follow for 30 days after surgery

• short term surgical outcome

  Patients will be follow for 30 days after surgery

• short term surgical outcome

  Patients will be follow for 30 days after surgery

• short term surgical outcome

  Patients will be follow for 30 days after surgery

Study Arms (2)

Grupp 1

ACTIVE COMPARATOR

Patients will be allocated to preserving the right gastric artery during the resection of GEJ cancer.

Diagnostic Test: Indocyanine Green

Grupp 2

ACTIVE COMPARATOR

Patients will be allocated to an extensive lymphatic resection (ligating the right gastric artery) during the resection of GEJ cancer.

Diagnostic Test: Indocyanine Green

Interventions

Indocyanine Green DIAGNOSTIC_TEST

Using Q-ICG perfusion of the remaining Gastric Conduit will be compared

Grupp 1; Grupp 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients (above 18 years) scheduled for planned open or robot-assisted resection of gastroesophageal junction cancer.

You may not qualify if:

• Allergy towards; iodine, indocyanine green or shellfish
• Severe liver insufficiency
• Thyrotoxicosis
• Nephropathy requiring dialysis
• Pregnancy or lactation
• Legally incompetent for any reason

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (60)

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  PMID: 36271062 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Jens TF Osterkamp, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD fellow, MD

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: September 27, 2019
• Study Start: June 16, 2020
• Primary Completion: October 13, 2021
• Study Completion: October 13, 2021
• Last Updated: October 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)