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Surgical AnastomosisNCT06270745

ICG Anastomotic Control in Digestive System Surgery

An observational study of Surgical Anastomosis, run by Shandong Linglong Yingcheng Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This was a parallel single-center retrospective cohort study conducted at Linglong Yingcheng Hospital, Shandong, China. The purpose of this study was to investigate the effect of indocyanine green (ICG) on patients undergoing digestive system surgery (subtotal gastrectomy, partial hepatectomy, transverse colectomy… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Surgical Anastomosis
What is being tested?
indocyanine green
Type of treatment
Injection or infusion
How many people
200 participants
Where
1 siteChina
Study dates
1 Jan 2018to 1 Jun 2024
How long will I take part?
30 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: A consecutive series of patients underwent digestive system surgery at our institution between January 1, 2018, and July 31, 2023

Who may be able to join

  • elective setting of surgery
  • digestive system surgery for benign or malignant pathology
  • 30 days of post-operative follow-up at least available from medical documentation
  • primary colo-colic or colo-rectal anastomosis with or without preventing ostomy
  • more than 18 years old, less than 90 years old

Who cannot join

  • terminal colonic stoma without anastomosis creation after demolitive step
  • extended transverse right hemicolectomy
  • left hemicolectomy with high vascular ligation
  • associated bowel or another splanchnic resection (i.e. neoplastic infiltration)
  • previous colic surgery
  • synchronous neoplasm
Show all 12Show fewer
  • not reporting in operating form details about vascular ligation
  • lack in reporting in medical records of primary outcomes
  • stage IV cancer
  • ASA IV
  • less than 18 years old, more then 90 years old
  • emergency setting

Trial locations and contacts

1 site in 1 country.

Ni Wang, MD,PD contact

8618705353551

wangni1989@163.com

China1 site, 1 recruiting
  • Shandong Linglong Yingcheng Hospital

    Yantai, Shandong, 264000

    Xuan Qiu, MD, 8618354280081, qiuxuan100@163.com

    Ni Wang, MD, 8618705353551, wangni1989@163.com

    Recruiting

Other trials in China

About this study

This was a parallel single-center retrospective cohort study conducted at Linglong Yingcheng Hospital, Shandong, China. The purpose of this study was to investigate the effect of indocyanine green (ICG) on patients undergoing digestive system surgery (subtotal gastrectomy, partial hepatectomy, transverse colectomy, left colectomy, including sigmoid resection, and splenic colic resection). ) of anastomotic leakage (AL). Secondary objectives were to detect and study the impact of various risk factors on AL and on morbidity and surgical performance within 30 days of surgery.

Read the detailed description

This was a parallel single-center retrospective cohort study observing a series of consecutive patients who underwent colorectal surgery at our institution between January 1, 2018, and December 31, 2023.

The primary endpoint of the study is AL at 30 days, and the secondary endpoint is postoperative morbidity of Clavien-Dindo score ≥ III within 30 days after surgery, including readmission and redo surgery, lymph node disease in patients with neoplastic disease Harvest, surgical site infection, laparoscopic surgery rate, and protected stoma rate.

According to the American Joint Committee on Cancer (AJJC) 8th edition, gender, body mass index, smoking, diabetes, cardiovascular disease, and tumor stage will be considered confounding factors in the development of AL.

A patient electronic database will be collected from medical records extracted from surgical logs and each digital medical record will be scanned to include perioperative outcomes and post-operative follow-up for 30 days after surgery, final readmission to the emergency room or any other department based on The following inclusion criteria, performed in the specialist ward of our local health institution: elective surgery, left colon segmental surgery: splenic colic resection, transverse colic resection and left hemicolectomy, defined as left hemicolectomy, low Mesenteric artery ligation and sigmoid resection, regardless of benign or malignant pathology, minimum 30 days of postoperative follow-up (available from medical documentation), primary colostomy or colorectal anastomosis with or without prophylactic ostomy ) and age of adulthood.

Exclusion criteria were distal colostomy without anastomosis after removal step, extended transverse right hemicolectomy, left hemicolectomy with high vascular ligation, resection of associated bowel or other viscera (ie, tumor infiltration), previous colic Surgery, synchronous tumors, failure to report vessel ligation in surgery form details, lack of medical record reporting of primary outcome, stage IV cancer, American Society Of Anestheasiologists (ASA) IV, under 18 years of age, and emergencies.

Reconstruction times vary with different anastomoses (colostomy or colorectal), techniques (staplers or hand suturing), and connections (side to side, side to end, end to side, or end to end).

Since 2018, our institute has been using ICG fluorescence laparoscopy, using a near-infrared (NIR) light source and a special oscilloscope and camera equipped with a xenon lamp; ICG is available as a sterile water-soluble lyophilized powder (Diagnostic Green® GmbH) . ICGICG fluorescence laparoscopy is routinely used in daily practice, following the following protocol: after specimen resection and before anastomosis, both colonic stumps or the colon and rectal stumps are examined with 5 cc of ICG 25 mg diluted in 10 cc of sterile aqueous solution .

Statistical analysis and sample size:

Quantitative variables will be described by mean ± standard deviation or median and IQR, and qualitative variables will be described by absolute frequency and percentage frequency. All continuous variables will be checked for normality. Comparisons of covariates will be performed using the Pearson X2 test or Fisher's exact test (for categorical variables) and the t test or Mann Whitney test (for continuous variables). Univariate analysis will be performed using logistic regression to examine the association of each predictor variable with anastomotic leak events. Next, variables with p<0.1 were considered for inclusion in the multivariable regression model. For each risk factor, the odds ratio is shown along with the associated confidence interval. All analyzes will be performed using spss version 27.0 statistical software with two-sided significance tests and a 5% significance level.

Being tested
indocyanine green
Keywords
Surgical Anastomosis,Anastomotic leak ,perfusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • indocyanine greenDrug

    Whether to use ICG to assess anastomotic perfusion during digestive system surgery

Study groups in NCT06270745
Study groupRoleWhat they receive
Indocyanine GreenIndocyanine green infusion during digestive system surgery
Receives: Drug: indocyanine green
non-Indocyanine GreenNo indocyanine green infusion during digestive system surgery
Receives: Drug: indocyanine green

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anastomotic leak at 30 days

    Anastomotic leak (a defect of intestinal wall at anastomotic site leading to a communication between the intra- and extraluminal compartments)at 30 days: abdominal CT scan IV and a Clavien Dindo Score ≥III

    Measured: 30 days

Secondary outcomes (1)
  1. Post-operative morbidity

    Clavien-Dindo score ≥III within 30 days from surgery including readmission and redo-surgery, harvested nodes for patients with neoplastic disease, Surgical Site Infection, rate of laparoscopic surgical procedure and rate of protection stoma.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2024
  2. Study start1 Jan 2018
  3. Primary completion1 Feb 2024
  4. Study completion1 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
Target duration
30 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT06270745
Sponsor's protocol ID
sdycllyy001
Status last verified
Feb 2024
First submitted
14 Feb 2024
Last updated
23 Feb 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Qiu X, Kashchenko VA, Zavrazhnov AA, Lankov TS, Ye L, Strizheletsky VV, Smirnov GA. Deep impact analysis of surgical strategy changes guided by indocyanine green fluorescence angiography in laparoscopic low anterior resection for rectal cancer. Int J Colorectal Dis. 2026 Jan 3;41(1):7. doi: 10.1007/s00384-025-05065-8.

    PubMed 41483178

Questions about this trial

What is this clinical trial studying?

An observational study of Surgical Anastomosis, run by Shandong Linglong Yingcheng Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xuan Qiu, MD (8618354280081, qiuxuan100@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anastomotic leak at 30 days (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06270745, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.

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