Gastric CancerPhase 4NCT05354856
The Effect of Chemoradiotherapy on Gastric Perfusion in Patients With Gastric Cancer.
A Phase 4 study testing Indocyanine green in people with Gastric Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
A study from our group (Osterkamp et al. in preparation) used ICG to evaluate intraoperative changes in gastric perfusion when reducing the circulating blood volume by blood withdrawal in pigs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Indocyanine green
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Mar 2022to 30 Dec 2023
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (above 18 years) scheduled for planned open or robot-assisted resection of gastric cancer.
Who cannot join
- Allergy towards; iodine, indocyanine green or shellfish
- Severe liver insufficiency
- Thyrotoxicosis
- Nephropathy requiring dialysis
- Pregnancy or lactation
- Legally incompetent for any reason
- Withdrawal of inclusion consent
- Disseminated disease or other that contraindicates curative surgery
Trial locations and contacts
1 site in 1 country.
About this study
A study from our group (Osterkamp et al. in preparation) used ICG to evaluate intraoperative changes in gastric perfusion when reducing the circulating blood volume by blood withdrawal in pigs. We saw a significant reduction in gastric perfusion with decreased blood volume, and this reduction of gastric perfusion was detectable with ICG. As data from a previous trial (PRESET phase 2 Protocol nr: H-15014904) has shown that chemotherapy decreases the circulating red blood cell volume in patients with gastroesophageal cancer, we wish to evaluate if standard care neoadjuvant chemotherapy also influences gastric perfusion. Gastric perfusion will be assessed during a screening laparoscopy (before chemotherapy) and then compared with a second assessment during gastric resection (after chemotherapy). The gastric perfusion will be measured using fluorescence-guided surgery with Indocyanine Green.
Participants will be offered the opportunity to have their blood volume measured during the trial. This is not required in order to take part in the fluorescence angiography part of the study.
Read the detailed description
Screening Laparoscopy:
As part of the standard care for gastric cancer, all patients undergo a screening laparoscopy before entering neoadjuvant chemotherapy. The procedure is performed to detect overt metastases not detected on the CT/PET-CT scans. First, the patient is placed under a standardized general anesthesia, and the laparoscopic set-up is completed. After anesthesia a peripheral arterial catheter will be placed in order acquire reading of cardia output and stroke volume. The patient will then be fluid optimized using a standardized stroke volume (SV) optimization algorithm. The abdomen is inspected visually for signs of metastatic disease. The small bowel is then manipulated, allowing for visualization of the stomach. A bolus of ICG (0.2 mg/kg body weight) will be injected intravenously and flushed with 5 mL of saline. Gastric perfusion will subsequently be assessed along specific regions of interest (ROI) with q-ICG to obtain baseline perfusion values.
As a substudy, 10 patients will have two measurements with ICG during the screening laparoscopy, one befor eand one after fluid optimization. These patients will receive an ICG dose of 0.1 mg/kg body weight per measurement, totalling 0.2 mg/kg after the two measurements.
Resection of gastric cancer:
The patient is placed under general anesthesia and after the stomach is visualized through surgical incision, a bolus of ICG (0.2 mg/kg body weight) will be injected intravenously and flushed with 5 mL of saline. The ROIs (the same ROIs as described in 3.7.1) will then be assessed with q-ICG. The anesthetic protocol will up to this point match that of the setting during the screening laparoscopy.
Fluorescence angiography:
During the screening laparoscopy, a laparoscope (telescope 30°, 5 mm, Arthrex Danmark A/S) will be connected to a camera system (Synergy, Arthrex Danmark A/S) and a light-source (Synergy Laser Light Source, Arthrex Danmark A/S) will supply the excitatory light and record the ICG angiography. The laparoscope will be fixed in a mechanical holding arm 10 cm from the tissue of interest, ensuring a stable position throughout the experiment.
Measuring of blood volume:
Hemoglobin mass (Hbmass) will be determined using a carbon monoxide (CO) rebreathing technique with a typical error of 1.0 %, as previously described (25). In brief, all individuals will rest for 20 min in the supine position before each measurement. During this time, a catheter will be inserted in an antecubital vein. Thereafter, 2 ml of blood will be sampled and analyzed immediately in triplicates for percentage carboxyhaemoglobin (% HbCO) and [Hb] (ABL800, Radiometer, Denmark). Subsequently, individuals will breathe 100 % O2 for 4 min to flush nitrogen from the airways. Then, a bolus of 1.5 ml kg-1 of 99.997 % chemically pure CO (CO N47, Air Liquide, France) will be administrated into the breathing circuit. Individuals will re-breath this gas mixture for 10 min. An additional 2 ml blood sample will be obtained and analyzed in triplicates. The change in % HbCO will be used to calculate Hbmass. Total RBCV, PV and BV will be derived from measures of Hbmass and hematocrit29.
The collected blood samples will not be stored after the measurement.
Statistics:
A comparison of the gastric perfusion before and after chemotherapy will be performed using Friedman's test or a repeated measures ANOVA / linear mixed-effects depending on a non- or parametric nature of the data. A P-value < 0.05 will be considered significant. Statistic evaluation will be performed using IBM SPSS Statistics © (v 22.0 SPSS Inc. Chicago, IL, USA).
- Conditions
- Gastric Cancer
- Being tested
- Indocyanine green
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine greenDrug
A bolus of ICG (0.2 mg/kg body weight) will be injected intravenously and flushed with 5 mL of saline. Gastric perfusion will subsequently be assessed along specific regions of interest (ROI) with q-ICG (quantitative perfusion assessments with ICG) to obtain baseline perfusion values.
| Study group | Role | What they receive |
|---|---|---|
| ICG patient | Experimental | All patients included in the study will be injected with ICG (0.2 mg/kg bodyweight) to assess gastric perfusion. Receives: Drug: Indocyanine green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in gastric perfusion
The primary endpoint is the difference in gastric perfusion (obtained with q-ICG, using the slope of the fluorescence curve (as described by Nerup et al)) before and after neoadjuvant chemotherapy.
A comparison of the gastric perfusion before and after chemotherapy will be performed using Friedman's test or a repeated measures ANOVA / linear mixed-effects depending on a non- or parametric nature of the data. A P-value < 0.05 will be considered significant. Statistic evaluation will be performed using IBM SPSS Statistics © (v 22.0 SPSS Inc. Chicago, IL, USA).
Measured: 2 years
Secondary outcomes (3)
Short term outcome
postoperative events and complications as graded by the Dindo-Clavien classification
Measured: 30 days after surgery
Short term outcome
Postoperative events as graded by the Comprehensive Complication Index
Measured: 30 days after surgery
Short term outcome
Length of hospital stay
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start11 Mar 2022
- Primary completion29 Dec 2023
- Study completion30 Dec 2023
Why it stopped: recruiting issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Only patients with resectable gastric cancer are included in the study
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JENS OSTERKAMP, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Jens TF Osterkamp, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354856
- Sponsor's protocol ID
- H-20027060
- Status last verified
- Apr 2024
- First submitted
- 15 Feb 2022
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Simonsen C, de Heer P, Bjerre ED, Suetta C, Hojman P, Pedersen BK, Svendsen LB, Christensen JF. Sarcopenia and Postoperative Complication Risk in Gastrointestinal Surgical Oncology: A Meta-analysis. Ann Surg. 2018 Jul;268(1):58-69. doi: 10.1097/SLA.0000000000002679.
PubMed 29373365Horowitz M, Neeman E, Sharon E, Ben-Eliyahu S. Exploiting the critical perioperative period to improve long-term cancer outcomes. Nat Rev Clin Oncol. 2015 Apr;12(4):213-26. doi: 10.1038/nrclinonc.2014.224. Epub 2015 Jan 20.
PubMed 25601442Pommergaard HC, Achiam MP, Burcharth J, Rosenberg J. Impaired blood supply in the colonic anastomosis in mice compromises healing. Int Surg. 2015 Jan;100(1):70-6. doi: 10.9738/INTSURG-D-13-00191.1.
PubMed 25594642Fawcett A, Shembekar M, Church JS, Vashisht R, Springall RG, Nott DM. Smoking, hypertension, and colonic anastomotic healing; a combined clinical and histopathological study. Gut. 1996 May;38(5):714-8. doi: 10.1136/gut.38.5.714.
PubMed 8707117Kim MJ, Shin R, Oh HK, Park JW, Jeong SY, Park JG. The impact of heavy smoking on anastomotic leakage and stricture after low anterior resection in rectal cancer patients. World J Surg. 2011 Dec;35(12):2806-10. doi: 10.1007/s00268-011-1286-1.
PubMed 21959931Kruschewski M, Rieger H, Pohlen U, Hotz HG, Buhr HJ. Risk factors for clinical anastomotic leakage and postoperative mortality in elective surgery for rectal cancer. Int J Colorectal Dis. 2007 Aug;22(8):919-27. doi: 10.1007/s00384-006-0260-0. Epub 2007 Jan 27.
PubMed 17260142Kassis 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.
PubMed 24075499Chadi SA, Fingerhut A, Berho M, DeMeester SR, Fleshman JW, Hyman NH, Margolin DA, Martz JE, McLemore EC, Molena D, Newman MI, Rafferty JF, Safar B, Senagore AJ, Zmora O, Wexner SD. Emerging Trends in the Etiology, Prevention, and Treatment of Gastrointestinal Anastomotic Leakage. J Gastrointest Surg. 2016 Dec;20(12):2035-2051. doi: 10.1007/s11605-016-3255-3. Epub 2016 Sep 16.
PubMed 27638764Trencheva K, Morrissey KP, Wells M, Mancuso CA, Lee SW, Sonoda T, Michelassi F, Charlson ME, Milsom JW. Identifying important predictors for anastomotic leak after colon and rectal resection: prospective study on 616 patients. Ann Surg. 2013 Jan;257(1):108-13. doi: 10.1097/SLA.0b013e318262a6cd.
PubMed 22968068Thompson SK, Chang EY, Jobe BA. Clinical review: Healing in gastrointestinal anastomoses, part I. Microsurgery. 2006;26(3):131-6. doi: 10.1002/micr.20197.
PubMed 16518804Christensen JF, Jones LW, Tolver A, Jorgensen LW, Andersen JL, Adamsen L, Hojman P, Nielsen RH, Rorth M, Daugaard G. Safety and efficacy of resistance training in germ cell cancer patients undergoing chemotherapy: a randomized controlled trial. Br J Cancer. 2014 Jul 8;111(1):8-16. doi: 10.1038/bjc.2014.273. Epub 2014 May 27.
PubMed 24867693Garski TR, Staller BJ, Hepner G, Banka VS, Finney RA Jr. Adverse reactions after administration of indocyanine green. JAMA. 1978 Aug 18;240(7):635. doi: 10.1001/jama.240.7.635b. No abstract available.
PubMed 671679Alander JT, Kaartinen I, Laakso A, Patila T, Spillmann T, Tuchin VV, Venermo M, Valisuo P. A review of indocyanine green fluorescent imaging in surgery. Int J Biomed Imaging. 2012;2012:940585. doi: 10.1155/2012/940585. Epub 2012 Apr 22.
PubMed 22577366Baiocchi GL, Diana M, Boni L. Indocyanine green-based fluorescence imaging in visceral and hepatobiliary and pancreatic surgery: State of the art and future directions. World J Gastroenterol. 2018 Jul 21;24(27):2921-2930. doi: 10.3748/wjg.v24.i27.2921.
PubMed 30038461Mangano A, Fernandes E, Gheza F, Bustos R, Chen LL, Masrur M, Giulianotti PC. Near-Infrared Indocyanine Green-Enhanced Fluorescence and Evaluation of the Bowel Microperfusion During Robotic Colorectal Surgery: a Retrospective Original Paper. Surg Technol Int. 2019 May 15;34:93-100.
PubMed 30716160
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chemoradiotherapy on Gastric Perfusion in Patients With Gastric Cancer.
- ClinicalTrials.gov ID
- NCT05354856
- Acronym / sponsor ID
- H-20027060
- Conditions
- Gastric Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruiting issues
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study from our group (Osterkamp et al. in preparation) used ICG to evaluate intraoperative changes in gastric perfusion when reducing the circulating blood volume by blood withdrawal in pigs. We saw a significant reduction in gastric perfusion with decreased blood volume, and this reduction of gastric perfusion was detectable with ICG. As data from a previous trial (PRESET phase 2 Protocol nr: H-15014904) has shown that chemotherapy decreases the circulating red blood cell volume in patients with gastroesophageal cancer, we wish to evaluate if standard care neoadjuvant chemotherapy also influences gastric perfusion. Gastric perfusion will be assessed during a screening laparoscopy (before chemotherapy) and then compared with a second assessment during gastric resection (after chemotherapy). The gastric perfusion will be measured using fluorescence-guided surgery with Indocyanine Green.
Participants will be offered the opportunity to have their blood volume measured during the trial. This is not required in order to take part in the fluorescence angiography part of the study.
Detailed description
Screening Laparoscopy:
As part of the standard care for gastric cancer, all patients undergo a screening laparoscopy before entering neoadjuvant chemotherapy. The procedure is performed to detect overt metastases not detected on the CT/PET-CT scans. First, the patient is placed under a standardized general anesthesia, and the laparoscopic set-up is completed. After anesthesia a peripheral arterial catheter will be placed in order acquire reading of cardia output and stroke volume. The patient will then be fluid optimized using a standardized stroke volume (SV) optimization algorithm. The abdomen is inspected visually for signs of metastatic disease. The small bowel is then manipulated, allowing for visualization of the stomach. A bolus of ICG (0.2 mg/kg body weight) will be injected intravenously and flushed with 5 mL of saline. Gastric perfusion will subsequently be assessed along specific regions of interest (ROI) with q-ICG to obtain baseline perfusion values.
As a substudy, 10 patients will have two measurements with ICG during the screening laparoscopy, one befor eand one after fluid optimization. These patients will receive an ICG dose of 0.1 mg/kg body weight per measurement, totalling 0.2 mg/kg after the two measurements.
Resection of gastric cancer:
The patient is placed under general anesthesia and after the stomach is visualized through surgical incision, a bolus of ICG (0.2 mg/kg body weight) will be injected intravenously and flushed with 5 mL of saline. The ROIs (the same ROIs as described in 3.7.1) will then be assessed with q-ICG. The anesthetic protocol will up to this point match that of the setting during the screening laparoscopy.
Fluorescence angiography:
During the screening laparoscopy, a laparoscope (telescope 30°, 5 mm, Arthrex Danmark A/S) will be connected to a camera system (Synergy, Arthrex Danmark A/S) and a light-source (Synergy Laser Light Source, Arthrex Danmark A/S) will supply the excitatory light and record the ICG angiography. The laparoscope will be fixed in a mechanical holding arm 10 cm from the tissue of interest, ensuring a stable position throughout the experiment.
Measuring of blood volume:
Hemoglobin mass (Hbmass) will be determined using a carbon monoxide (CO) rebreathing technique with a typical error of 1.0 %, as previously described (25). In brief, all individuals will rest for 20 min in the supine position before each measurement. During this time, a catheter will be inserted in an antecubital vein. Thereafter, 2 ml of blood will be sampled and analyzed immediately in triplicates for percentage carboxyhaemoglobin (% HbCO) and [Hb] (ABL800, Radiometer, Denmark). Subsequently, individuals will breathe 100 % O2 for 4 min to flush nitrogen from the airways. Then, a bolus of 1.5 ml kg-1 of 99.997 % chemically pure CO (CO N47, Air Liquide, France) will be administrated into the breathing circuit. Individuals will re-breath this gas mixture for 10 min. An additional 2 ml blood sample will be obtained and analyzed in triplicates. The change in % HbCO will be used to calculate Hbmass. Total RBCV, PV and BV will be derived from measures of Hbmass and hematocrit29.
The collected blood samples will not be stored after the measurement.
Statistics:
A comparison of the gastric perfusion before and after chemotherapy will be performed using Friedman's test or a repeated measures ANOVA / linear mixed-effects depending on a non- or parametric nature of the data. A P-value < 0.05 will be considered significant. Statistic evaluation will be performed using IBM SPSS Statistics © (v 22.0 SPSS Inc. Chicago, IL, USA).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Only patients with resectable gastric cancer are included in the study
| Arm | Type | Receives |
|---|---|---|
| ICG patient | Experimental | Drug: Indocyanine greenAll patients included in the study will be injected with ICG (0.2 mg/kg bodyweight) to assess gastric perfusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients (above 18 years) scheduled for planned open or robot-assisted resection of gastric cancer.
Key exclusion criteria (8 listed)
- Allergy towards; iodine, indocyanine green or shellfish
- Severe liver insufficiency
- Thyrotoxicosis
- Nephropathy requiring dialysis
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indocyanine greenA bolus of ICG (0.2 mg/kg body weight) will be injected intravenously and flushed with 5 mL of saline. Gastric perfusion will subsequently be assessed along specific regions of interest (ROI) with q-ICG (quantitative perfusion assessments with ICG) to obtain baseline perfusion values. | Drug | ICG patient |
Primary outcome
Difference in gastric perfusion
Time frame: 2 years
The primary endpoint is the difference in gastric perfusion (obtained with q-ICG, using the slope of the fluorescence curve (as described by Nerup et al)) before and after neoadjuvant chemotherapy. A comparison of the gastric perfusion before and after chemotherapy will be performed using Friedman's test or a repeated measures ANOVA / linear mixed-effects depending on a non- or parametric nature of the data. A P-value < 0.05 will be considered significant. Statistic evaluation will be performed using IBM SPSS Statistics © (v 22.0 SPSS Inc. Chicago, IL, USA).
3 secondary outcomes
Short term outcome
Time frame: 30 days after surgery
Short term outcome
Time frame: 30 days after surgery
Short term outcome
Time frame: 30 days after surgery
Results and safety
The study was stopped early (reason given: recruiting issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Background: PubMed 29373365Simonsen C, de Heer P, Bjerre ED, Suetta C, Hojman P, Pedersen BK, Svendsen LB, Christensen JF. Sarcopenia and Postoperative Complication Risk in Gastrointestinal Surgical Oncology: A Meta-analysis. Ann Surg. 2018 Jul;268(1):58-69. doi: 10.1097/SLA.0000000000002679.
- Background: PubMed 25601442Horowitz M, Neeman E, Sharon E, Ben-Eliyahu S. Exploiting the critical perioperative period to improve long-term cancer outcomes. Nat Rev Clin Oncol. 2015 Apr;12(4):213-26. doi: 10.1038/nrclinonc.2014.224. Epub 2015 Jan 20.
- Background: PubMed 25594642Pommergaard HC, Achiam MP, Burcharth J, Rosenberg J. Impaired blood supply in the colonic anastomosis in mice compromises healing. Int Surg. 2015 Jan;100(1):70-6. doi: 10.9738/INTSURG-D-13-00191.1.
- Background: PubMed 8707117Fawcett A, Shembekar M, Church JS, Vashisht R, Springall RG, Nott DM. Smoking, hypertension, and colonic anastomotic healing; a combined clinical and histopathological study. Gut. 1996 May;38(5):714-8. doi: 10.1136/gut.38.5.714.
- Background: PubMed 21959931Kim MJ, Shin R, Oh HK, Park JW, Jeong SY, Park JG. The impact of heavy smoking on anastomotic leakage and stricture after low anterior resection in rectal cancer patients. World J Surg. 2011 Dec;35(12):2806-10. doi: 10.1007/s00268-011-1286-1.
- Background: PubMed 17260142Kruschewski M, Rieger H, Pohlen U, Hotz HG, Buhr HJ. Risk factors for clinical anastomotic leakage and postoperative mortality in elective surgery for rectal cancer. Int J Colorectal Dis. 2007 Aug;22(8):919-27. doi: 10.1007/s00384-006-0260-0. Epub 2007 Jan 27.
- Background: PubMed 24075499Kassis 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.
- Background: PubMed 27638764Chadi SA, Fingerhut A, Berho M, DeMeester SR, Fleshman JW, Hyman NH, Margolin DA, Martz JE, McLemore EC, Molena D, Newman MI, Rafferty JF, Safar B, Senagore AJ, Zmora O, Wexner SD. Emerging Trends in the Etiology, Prevention, and Treatment of Gastrointestinal Anastomotic Leakage. J Gastrointest Surg. 2016 Dec;20(12):2035-2051. doi: 10.1007/s11605-016-3255-3. Epub 2016 Sep 16.
- Background: PubMed 22968068Trencheva K, Morrissey KP, Wells M, Mancuso CA, Lee SW, Sonoda T, Michelassi F, Charlson ME, Milsom JW. Identifying important predictors for anastomotic leak after colon and rectal resection: prospective study on 616 patients. Ann Surg. 2013 Jan;257(1):108-13. doi: 10.1097/SLA.0b013e318262a6cd.
- Background: PubMed 16518804Thompson SK, Chang EY, Jobe BA. Clinical review: Healing in gastrointestinal anastomoses, part I. Microsurgery. 2006;26(3):131-6. doi: 10.1002/micr.20197.
- Background: PubMed 24867693Christensen JF, Jones LW, Tolver A, Jorgensen LW, Andersen JL, Adamsen L, Hojman P, Nielsen RH, Rorth M, Daugaard G. Safety and efficacy of resistance training in germ cell cancer patients undergoing chemotherapy: a randomized controlled trial. Br J Cancer. 2014 Jul 8;111(1):8-16. doi: 10.1038/bjc.2014.273. Epub 2014 May 27.
- Background: PubMed 671679Garski TR, Staller BJ, Hepner G, Banka VS, Finney RA Jr. Adverse reactions after administration of indocyanine green. JAMA. 1978 Aug 18;240(7):635. doi: 10.1001/jama.240.7.635b. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens TF Osterkamp, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Indocyanine green in people with Gastric Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 1 inclusion and 8 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: stopped early, as of the sponsor's last update on 2 May 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: recruiting issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in gastric perfusion (time frame: 2 years). 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 NCT05354856, which also lists 27 linked publications.
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 2 May 2024.