Esophagus CancerSuperchargedNCT05954702
Supercharged TRAM Evaluation in Cervical Esophagogastroplasty After Esophagectomy
A study testing Supercharged TRAM esophagectomy and Conventional Esophagectomy in people with Esophagus Cancer and Carcinoma Esophagus, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial summary
Esophagectomy has high rates of morbidity and mortality, in many cases due to esophagus reconstruction. Anastomotic leakage and fistula are the main esophagectomy complications. Many studies underwent to investigate the cause for anastomotic leakage after esophagectomy, however none of them conclude it is related to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagus Cancer, Carcinoma Esophagus
- What is being tested?
- Supercharged TRAM esophagectomy and Conventional Esophagectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 21 Jul 2023to Oct 2026
- Phase
- Interventional
- 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
- Diagnosis of esophageal malignancy cancer;
- Ability to understand and collaborate during treatment;
Who cannot join
- Previous gastrectomy;
- Previous abdominal surgery with risk of altering stomach vascularization;
- Previous head and neck surgery with risk of alteration of cervical vessels.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Cancer do Estado de São Paulo (ICESP)
São Paulo, São Paulo, 01246000
Flavio Takeda, MD
Flavio Takeda, MD
About this study
Esophagectomy has high rates of morbidity and mortality, in many cases due to esophagus reconstruction. Anastomotic leakage and fistula are the main esophagectomy complications. Many studies underwent to investigate the cause for anastomotic leakage after esophagectomy, however none of them conclude it is related to surgery or suture technique. However, it seems to be triggered by the ischemia caused after stomach mobilization to esophagus reconstruction, or even tension in the anastomosis.
Considering the post esophagectomy with gastroplasty high morbidity and mortality rates, strategies to create a new vascularization source and decrease anastomotic leakage rates is important. In this study researchers will evaluate whether a TRAM flap transfer supercharged is effective on decrease morbidity related to anastomosis ischemia in patients undergoing esophagectomy.
Read the detailed description
The transfer of muscle parts is one of the main reconstruction techniques used in plastic surgery. Transverse rectus abdominis myocutaneous (TRAM) flap transfers are very considered due to high quality results, wide application in many cases, and small number of reviews in long term.
Beegle, in 1991 published a new technique of using TRAM supercharged in which microsurgical anastomosis are used between TRAM's unipedicled gastroepiploic deep artery and veins and thoracic branches and vessels, such as axillary and thoracodorsal vessels.
Looking for recover tissue blood perfusion and decrease morbidity rates associated with anastomosis ischemia, some studies showed large intestine or jejunum interposition plus an additional blood supply through venous and arterial anastomosis - colon or jejunum supercharged is effective. The isoperistaltic supercharged colon interposition was a good option to rebuild big esophagus parts in which stomach was not available.
Considering the post esophagectomy with gastroplasty high morbidity and mortality rates, strategies to create a new vascularization source and decrease anastomotic leakage rates is important. This is a single-institution, randomized clinical trial with participants recruited in the digestive system surgery clinic, at the Instituto do Câncer do Estado de São Paulo (ICESP). Patients will be randomized to conventional esophagectomy or TRAM supercharged esophagectomy, and researchers will evaluate post-operatory complications in both groups.
- Conditions
- Esophagus Cancer, Carcinoma Esophagus
- Being tested
- Supercharged TRAM esophagectomy, Conventional Esophagectomy
- Keywords
- Esophagectomy, Esophagogastroplasty, Supercharged
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supercharged TRAM esophagectomyProcedure or surgery
Esophagectomy, immediately followed by supercharged esophagogastroplasty. Use the transverse rectus abdominis myocutaneous (TRAM) flap transfers to surgically create a new anastomosis in the left gastroepiploic vessels.
Conventional EsophagectomyProcedure or surgery
Esophagectomy, immediately followed by an esophagus reconstruction trough esophagogastroplasty.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Esophagectomy group | Active comparator | Patients with malignant esophagus neoplasms randomized to Conventional Esophagectomy will undergo to an esophagectomy, immediately followed by an esophagus reconstruction trough esophagogastroplasty. Receives: Procedure: Conventional Esophagectomy |
| Supercharged TRAM esophagectomy group | Experimental | Patients with malignant esophagus neoplasms randomized to Supercharged TRAM esophagectomy will undergo to esophagectomy, immediately followed by supercharged esophagogastroplasty. Receives: Procedure: Supercharged TRAM esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence and number of post-operatory complications
surgical wound infection, hematoma, anastomotic leakage, stenosis, chylothorax and clinical complications due to hospitalization
Measured: Until 1 year after Surgery
Mortality
Patients who and when died
Measured: Until 1 year after surgery after surgery
Secondary outcomes (5)
Days in intensive care unit
Number of days patient will stay at intensive care unit
Measured: From the surgery day until the date patient leave intensive care unit
Hospitalization period
Number of days patient will stay in hospital after surgery
Measured: From the surgery day until the date patient leave hospital
Need of vasoactive drugs
If patient use vasoactive drugs drugs hospitalization
Measured: From the surgery day until the date patient leave hospital
Blood transfusion need
If patients need blood transfusion during hospitalization
Measured: From the surgery day until the date patient leave hospital
Drain use time
How long patient use drain
Measured: From the surgery day until the date patient took off drain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start21 Jul 2023
- Primary completionJul 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (46)Papers the sponsor has linked to this study.
- Other trials for Esophagus CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Flavio Takeda, PhD, MD, Principal investigator, Instituto do Cancer do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954702
- Sponsor's protocol ID
- NP 1683
- Acronym
- Supercharged
- Status last verified
- Jun 2023
- First submitted
- 30 Jun 2023
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akiyama H. Surgery for carcinoma of the esophagus. Curr Probl Surg. 1980 Feb;17(2):53-120. doi: 10.1016/s0011-3840(80)80025-6. No abstract available.
PubMed 6987040Akiyama H, Miyazono H, Tsurumaru M, Hashimoto C, Kawamura T. Use of the stomach as an esophageal substitute. Ann Surg. 1978 Nov;188(5):606-10. doi: 10.1097/00000658-197811000-00004.
PubMed 718285Barzin A, Norton JA, Whyte R, Lee GK. Supercharged jejunum flap for total esophageal reconstruction: single-surgeon 3-year experience and outcomes analysis. Plast Reconstr Surg. 2011 Jan;127(1):173-180. doi: 10.1097/PRS.0b013e3181f95a36.
PubMed 21200211Bourke MJ, Hope RL, Chu G, Gillespie PE, Bull C, O'Rourke I, Williams SJ. Laser palliation of inoperable malignant dysphagia: initial and at death. Gastrointest Endosc. 1996 Jan;43(1):29-32. doi: 10.1016/s0016-5107(96)70256-0.
PubMed 8903814Briel JW, Tamhankar AP, Hagen JA, DeMeester SR, Johansson J, Choustoulakis E, Peters JH, Bremner CG, DeMeester TR. Prevalence and risk factors for ischemia, leak, and stricture of esophageal anastomosis: gastric pull-up versus colon interposition. J Am Coll Surg. 2004 Apr;198(4):536-41; discussion 541-2. doi: 10.1016/j.jamcollsurg.2003.11.026.
PubMed 15051003Buskens CJ, Hulscher JB, Fockens P, Obertop H, van Lanschot JJ. Benign tracheo-neo-esophageal fistulas after subtotal esophagectomy. Ann Thorac Surg. 2001 Jul;72(1):221-4. doi: 10.1016/s0003-4975(01)02701-1.
PubMed 11465183Collard JM, Tinton N, Malaise J, Romagnoli R, Otte JB, Kestens PJ. Esophageal replacement: gastric tube or whole stomach? Ann Thorac Surg. 1995 Aug;60(2):261-6; discussion 267. doi: 10.1016/0003-4975(95)00411-d.
PubMed 7646084D'Amico TA, Harpole DH Jr. Molecular biology of esophageal cancer. Chest Surg Clin N Am. 2000 Aug;10(3):451-69.
PubMed 10967750Domper Arnal MJ, Ferrandez Arenas A, Lanas Arbeloa A. Esophageal cancer: Risk factors, screening and endoscopic treatment in Western and Eastern countries. World J Gastroenterol. 2015 Jul 14;21(26):7933-43. doi: 10.3748/wjg.v21.i26.7933.
PubMed 26185366Edsander-Nord A, Jurell G, Wickman M. Donor-site morbidity after pedicled or free TRAM flap surgery: a prospective and objective study. Plast Reconstr Surg. 1998 Oct;102(5):1508-16. doi: 10.1097/00006534-199810000-00025.
PubMed 9774004El-Mrakby HH, Milner RH, McLean NR. Supercharged pedicled TRAM flap in breast reconstruction: is it a worthwhile procedure. Ann Plast Surg. 2002 Sep;49(3):252-7. doi: 10.1097/00000637-200209000-00003.
PubMed 12351972Ferguson A, Kingstone K. Coeliac disease and malignancies. Acta Paediatr Suppl. 1996 May;412:78-81. doi: 10.1111/j.1651-2227.1996.tb14259.x.
PubMed 8783767Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
PubMed 25220842Garcia-Vasquez C, Fernandez-Acenero MJ, Garcia Gomez-Heras S, Pastor C. Fibrin patch influences the expression of hypoxia-inducible factor-1alpha and nuclear factor-kappaBp65 factors on ischemic intestinal anastomosis. Exp Biol Med (Maywood). 2018 Jun;243(10):803-808. doi: 10.1177/1535370218777216.
PubMed 29932372GARLOCK JH. Resection of thoracic esophagus for carcinoma located above arch of aorta; cervical esophagogastrostomy. Surgery. 1948 Jul;24(1):1-8. No abstract available.
PubMed 18872828
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supercharged TRAM Evaluation in Cervical Esophagogastroplasty After Esophagectomy
- ClinicalTrials.gov ID
- NCT05954702
- Acronym / sponsor ID
- Supercharged / NP 1683
- Conditions
- Esophagus Cancer, Carcinoma Esophagus
- Keywords
- Esophagectomy, Esophagogastroplasty, Supercharged
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 20 Jul 2023 (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.
Esophagectomy has high rates of morbidity and mortality, in many cases due to esophagus reconstruction. Anastomotic leakage and fistula are the main esophagectomy complications. Many studies underwent to investigate the cause for anastomotic leakage after esophagectomy, however none of them conclude it is related to surgery or suture technique. However, it seems to be triggered by the ischemia caused after stomach mobilization to esophagus reconstruction, or even tension in the anastomosis.
Considering the post esophagectomy with gastroplasty high morbidity and mortality rates, strategies to create a new vascularization source and decrease anastomotic leakage rates is important. In this study researchers will evaluate whether a TRAM flap transfer supercharged is effective on decrease morbidity related to anastomosis ischemia in patients undergoing esophagectomy.
Detailed description
The transfer of muscle parts is one of the main reconstruction techniques used in plastic surgery. Transverse rectus abdominis myocutaneous (TRAM) flap transfers are very considered due to high quality results, wide application in many cases, and small number of reviews in long term.
Beegle, in 1991 published a new technique of using TRAM supercharged in which microsurgical anastomosis are used between TRAM's unipedicled gastroepiploic deep artery and veins and thoracic branches and vessels, such as axillary and thoracodorsal vessels.
Looking for recover tissue blood perfusion and decrease morbidity rates associated with anastomosis ischemia, some studies showed large intestine or jejunum interposition plus an additional blood supply through venous and arterial anastomosis - colon or jejunum supercharged is effective. The isoperistaltic supercharged colon interposition was a good option to rebuild big esophagus parts in which stomach was not available.
Considering the post esophagectomy with gastroplasty high morbidity and mortality rates, strategies to create a new vascularization source and decrease anastomotic leakage rates is important. This is a single-institution, randomized clinical trial with participants recruited in the digestive system surgery clinic, at the Instituto do Câncer do Estado de São Paulo (ICESP). Patients will be randomized to conventional esophagectomy or TRAM supercharged esophagectomy, and researchers will evaluate post-operatory complications in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Esophagectomy group | Active comparator | Procedure: Conventional EsophagectomyPatients with malignant esophagus neoplasms randomized to Conventional Esophagectomy will undergo to an esophagectomy, immediately followed by an esophagus reconstruction trough esophagogastroplasty. |
| Supercharged TRAM esophagectomy group | Experimental | Procedure: Supercharged TRAM esophagectomyPatients with malignant esophagus neoplasms randomized to Supercharged TRAM esophagectomy will undergo to esophagectomy, immediately followed by supercharged esophagogastroplasty. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of esophageal malignancy cancer;
- Ability to understand and collaborate during treatment;
Key exclusion criteria (3 listed)
- Previous gastrectomy;
- Previous abdominal surgery with risk of altering stomach vascularization;
- Previous head and neck surgery with risk of alteration of cervical vessels.
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 |
|---|---|---|
| Supercharged TRAM esophagectomyEsophagectomy, immediately followed by supercharged esophagogastroplasty. Use the transverse rectus abdominis myocutaneous (TRAM) flap transfers to surgically create a new anastomosis in the left gastroepiploic vessels. | Procedure or surgery | Supercharged TRAM esophagectomy group |
| Conventional EsophagectomyEsophagectomy, immediately followed by an esophagus reconstruction trough esophagogastroplasty. | Procedure or surgery | Conventional Esophagectomy group |
Primary outcome
Presence and number of post-operatory complications
Time frame: Until 1 year after Surgery
surgical wound infection, hematoma, anastomotic leakage, stenosis, chylothorax and clinical complications due to hospitalization
Mortality
Time frame: Until 1 year after surgery after surgery
Patients who and when died
5 secondary outcomes
Days in intensive care unit
Time frame: From the surgery day until the date patient leave intensive care unit
Hospitalization period
Time frame: From the surgery day until the date patient leave hospital
Need of vasoactive drugs
Time frame: From the surgery day until the date patient leave hospital
Blood transfusion need
Time frame: From the surgery day until the date patient leave hospital
Drain use time
Time frame: From the surgery day until the date patient took off drain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Background: PubMed 6987040Akiyama H. Surgery for carcinoma of the esophagus. Curr Probl Surg. 1980 Feb;17(2):53-120. doi: 10.1016/s0011-3840(80)80025-6. No abstract available.
- Background: PubMed 718285Akiyama H, Miyazono H, Tsurumaru M, Hashimoto C, Kawamura T. Use of the stomach as an esophageal substitute. Ann Surg. 1978 Nov;188(5):606-10. doi: 10.1097/00000658-197811000-00004.
- Background: PubMed 21200211Barzin A, Norton JA, Whyte R, Lee GK. Supercharged jejunum flap for total esophageal reconstruction: single-surgeon 3-year experience and outcomes analysis. Plast Reconstr Surg. 2011 Jan;127(1):173-180. doi: 10.1097/PRS.0b013e3181f95a36.
- Background: PubMed 8903814Bourke MJ, Hope RL, Chu G, Gillespie PE, Bull C, O'Rourke I, Williams SJ. Laser palliation of inoperable malignant dysphagia: initial and at death. Gastrointest Endosc. 1996 Jan;43(1):29-32. doi: 10.1016/s0016-5107(96)70256-0.
- Background: PubMed 15051003Briel JW, Tamhankar AP, Hagen JA, DeMeester SR, Johansson J, Choustoulakis E, Peters JH, Bremner CG, DeMeester TR. Prevalence and risk factors for ischemia, leak, and stricture of esophageal anastomosis: gastric pull-up versus colon interposition. J Am Coll Surg. 2004 Apr;198(4):536-41; discussion 541-2. doi: 10.1016/j.jamcollsurg.2003.11.026.
- Background: PubMed 11465183Buskens CJ, Hulscher JB, Fockens P, Obertop H, van Lanschot JJ. Benign tracheo-neo-esophageal fistulas after subtotal esophagectomy. Ann Thorac Surg. 2001 Jul;72(1):221-4. doi: 10.1016/s0003-4975(01)02701-1.
- Background: PubMed 7646084Collard JM, Tinton N, Malaise J, Romagnoli R, Otte JB, Kestens PJ. Esophageal replacement: gastric tube or whole stomach? Ann Thorac Surg. 1995 Aug;60(2):261-6; discussion 267. doi: 10.1016/0003-4975(95)00411-d.
- Background: PubMed 10967750D'Amico TA, Harpole DH Jr. Molecular biology of esophageal cancer. Chest Surg Clin N Am. 2000 Aug;10(3):451-69.
- Background: PubMed 26185366Domper Arnal MJ, Ferrandez Arenas A, Lanas Arbeloa A. Esophageal cancer: Risk factors, screening and endoscopic treatment in Western and Eastern countries. World J Gastroenterol. 2015 Jul 14;21(26):7933-43. doi: 10.3748/wjg.v21.i26.7933.
- Background: PubMed 9774004Edsander-Nord A, Jurell G, Wickman M. Donor-site morbidity after pedicled or free TRAM flap surgery: a prospective and objective study. Plast Reconstr Surg. 1998 Oct;102(5):1508-16. doi: 10.1097/00006534-199810000-00025.
- Background: PubMed 12351972El-Mrakby HH, Milner RH, McLean NR. Supercharged pedicled TRAM flap in breast reconstruction: is it a worthwhile procedure. Ann Plast Surg. 2002 Sep;49(3):252-7. doi: 10.1097/00000637-200209000-00003.
- Background: PubMed 8783767Ferguson A, Kingstone K. Coeliac disease and malignancies. Acta Paediatr Suppl. 1996 May;412:78-81. doi: 10.1111/j.1651-2227.1996.tb14259.x.
- Individual participant dataSharing planned: No
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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.
Flavio Takeda, PhD, MD principal investigator
Instituto do Cancer do Estado de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supercharged TRAM esophagectomy and Conventional Esophagectomy in people with Esophagus Cancer and Carcinoma Esophagus, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
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 2 inclusion and 3 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 16 Oct 2023. 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 Brazil. 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 Flavio Takeda, PhD, MD (+55 11 999079973, flavio.takeda@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence and number of post-operatory complications (time frame: Until 1 year after Surgery). The study lists 2 primary outcomes in all. 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 NCT05954702, which also lists 46 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 16 Oct 2023.