Perfusion Rate Assessment by Near-infrared Fluorescence in Gastrointestinal Anastomoses

NCT04709445 | Unknown

• 1 other identifier: EA1/087/20
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In this prospective, non-randomized cohort study, real-time intraoperative visualization using near-infrared-fluorescence by indocyanine green injection (ICG-NIRF) is performed at two to three time points during procedures of upper GI, lower GI and hepatobiliary surgery with anastomosis formation in open or laparoscopic surgery. Postoperatively, a detailed software-based assessment of each recording is performed to determine the objective ICG-NIRF perfusion rate before and after anastomosis formation, which is then correlated with the 30 day postoperative clinical outcome including occurrence of anastomotic leak.

Conditions

Bowel Obstruction; Bowel Ischemia; Diverticulitis; Abnormality of the Gastrointestinal Tract; Symptomatic Disorders of the Gastrointestinal Tract; Stoma Ileostomy; Cancer of the Gastrointestinal Tract; Crohn Disease; Ulcerative Colitis; Familial Adenomatous Polyposis; Pancreatic Neoplasms; Hepatobiliary Neoplasm

Keywords

indocyanine green; objective perfusion rate; near infrared fluorescence; anastomotic leak; image guided surgery; anastomosis; perfusion assessment

Outcome Measures

Primary Outcomes (1)

• anastomotic leak

  number of patients suffering from an anastomotic leak within 30 days of operation

  30 days

Secondary Outcomes (2)

• Operative and post-operative complications

  30 days

• Length of hospital stay

  100 days

Study Arms (1)

ICG-NIRF Imaging and objective perfusion rate

EXPERIMENTAL

Intraoperatively, ICG-NIRF imaging is used to visualize the blood supply and the rate of tissue perfusion in the area of the anastomotic site. Postoperatively, an additional ingress and egress analysis at specific regions of interest is performed.

Diagnostic Test: ICG-NIRF Imaging plus ingress and egress analysis

Interventions

ICG-NIRF Imaging plus ingress and egress analysis DIAGNOSTIC_TEST

intraoperative NIRF Imaging using the fluorescence agent ICG (indocyanine-green) before and after anastomosis formation, postoperative analysis of ingress and egress for specific regions of interest

ICG-NIRF Imaging and objective perfusion rate

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18
• capability of signing informed consent
• diagnosis of malignancies of the upper gastrointestinal tract (GI), or malignancies of the lower GI, or malignancies of the hepatobiliary system, refractory ulcerative colitis, or Crohn's disease, or acute, inflammatory, degenerative functional or anatomical disorders
• Surgery possible and medically indicated to the diagnosis (esophageal resection, or subtotal or total gastrectomy, or Y-Roux reconstruction, or right or left colonic interposition, or small bowel segment resection, or ileocecal resection, or colectomy, or proctectomy with restorative ileoanal pouch (one or two-stage), or left or right hemicolectomy, or sigmoid resection, or rectal resection (deep anterior resection (TAR)), or proctectomy with colo-anal anastomosis, or abdominoperineal resection, or stoma closure, or pancreaticoduodenectomy

You may not qualify if:

• liver disfunction (MELD score \> 10)
• pregnancy or breastfeeding

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité Campus Benjamin Franklin

Berlin, 12203, Germany

RECRUITING

Related Publications (5)

• Kassis ES, Kosinski AS, Ross P Jr, Koppes KE, Donahue JM, Daniel VC. Predictors of anastomotic leak after esophagectomy: an analysis of the society of thoracic surgeons general thoracic database. Ann Thorac Surg. 2013 Dec;96(6):1919-26. doi: 10.1016/j.athoracsur.2013.07.119. Epub 2013 Sep 24.

  PMID: 24075499 BACKGROUND

• McDermott FD, Heeney A, Kelly ME, Steele RJ, Carlson GL, Winter DC. Systematic review of preoperative, intraoperative and postoperative risk factors for colorectal anastomotic leaks. Br J Surg. 2015 Apr;102(5):462-79. doi: 10.1002/bjs.9697. Epub 2015 Feb 19.

  PMID: 25703524 BACKGROUND

• van den Bos J, Jongen ACHM, Melenhorst J, Breukink SO, Lenaerts K, Schols RM, Bouvy ND, Stassen LPS. Near-infrared fluorescence image-guidance in anastomotic colorectal cancer surgery and its relation to serum markers of anastomotic leakage: a clinical pilot study. Surg Endosc. 2019 Nov;33(11):3766-3774. doi: 10.1007/s00464-019-06673-6. Epub 2019 Feb 1.

  PMID: 30710314 BACKGROUND

• van den Bos J, Al-Taher M, Schols RM, van Kuijk S, Bouvy ND, Stassen LPS. Near-Infrared Fluorescence Imaging for Real-Time Intraoperative Guidance in Anastomotic Colorectal Surgery: A Systematic Review of Literature. J Laparoendosc Adv Surg Tech A. 2018 Feb;28(2):157-167. doi: 10.1089/lap.2017.0231. Epub 2017 Nov 6.

  PMID: 29106320 BACKGROUND

• Degett TH, Andersen HS, Gogenur I. Indocyanine green fluorescence angiography for intraoperative assessment of gastrointestinal anastomotic perfusion: a systematic review of clinical trials. Langenbecks Arch Surg. 2016 Sep;401(6):767-75. doi: 10.1007/s00423-016-1400-9. Epub 2016 Mar 11.

  PMID: 26968863 BACKGROUND

MeSH Terms

Conditions

Intestinal Obstruction; Diverticulitis; Gastrointestinal Neoplasms; Crohn Disease; Colitis, Ulcerative; Adenomatous Polyposis Coli; Pancreatic Neoplasms; Anastomotic Leak

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Diverticular Diseases; Gastroenteritis; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Inflammatory Bowel Diseases; Colitis; Colonic Diseases; Adenomatous Polyps; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Colorectal Neoplasms; Intestinal Neoplasms; Neoplastic Syndromes, Hereditary; Intestinal Polyposis; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Benjamin Weixler, PD MD

CONTACT

+49 30 450 622 798; benjamin.weixler@charite.de

Leonard Lobbes, MD

CONTACT

+49 30 450 622 789; leonard.lobbes@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Assistant Professor

Model Details: This is a non-randomised prospective cohort study design.

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 14, 2021
• Study Start: March 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 14, 2021

Record last verified: 2021-01

Locations

DE (1)