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Supercharged TRAM Evaluation in Cervical Esophagogastroplasty After Esophagectomy (Supercharged)

Primary Purpose

Esophagus Cancer, Carcinoma Esophagus

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Supercharged TRAM esophagectomy
Conventional Esophagectomy
Sponsored by
Instituto do Cancer do Estado de São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophagus Cancer focused on measuring Esophagectomy, Esophagogastroplasty, Supercharged

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of esophageal malignancy cancer; Ability to understand and collaborate during treatment; Exclusion Criteria: Previous gastrectomy; Previous abdominal surgery with risk of altering stomach vascularization; Previous head and neck surgery with risk of alteration of cervical vessels.

Sites / Locations

  • Instituto do Cancer do Estado de São Paulo (ICESP)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Esophagectomy group

Supercharged TRAM esophagectomy group

Arm Description

Patients with malignant esophagus neoplasms randomized to Conventional Esophagectomy will undergo to an esophagectomy, immediately followed by an esophagus reconstruction trough esophagogastroplasty.

Patients with malignant esophagus neoplasms randomized to Supercharged TRAM esophagectomy will undergo to esophagectomy, immediately followed by supercharged esophagogastroplasty.

Outcomes

Primary Outcome Measures

Presence and number of post-operatory complications
surgical wound infection, hematoma, anastomotic leakage, stenosis, chylothorax and clinical complications due to hospitalization
Mortality
Patients who and when died

Secondary Outcome Measures

Days in intensive care unit
Number of days patient will stay at intensive care unit
Hospitalization period
Number of days patient will stay in hospital after surgery
Need of vasoactive drugs
If patient use vasoactive drugs drugs hospitalization
Blood transfusion need
If patients need blood transfusion during hospitalization
Drain use time
How long patient use drain

Full Information

First Posted
June 30, 2023
Last Updated
October 13, 2023
Sponsor
Instituto do Cancer do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT05954702
Brief Title
Supercharged TRAM Evaluation in Cervical Esophagogastroplasty After Esophagectomy
Acronym
Supercharged
Official Title
Supercharged TRAM Evaluation in Cervical Esophagogastroplasty After Esophagectomy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2023 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto do Cancer do Estado de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagus Cancer, Carcinoma Esophagus
Keywords
Esophagectomy, Esophagogastroplasty, Supercharged

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional Esophagectomy group
Arm Type
Active Comparator
Arm Description
Patients with malignant esophagus neoplasms randomized to Conventional Esophagectomy will undergo to an esophagectomy, immediately followed by an esophagus reconstruction trough esophagogastroplasty.
Arm Title
Supercharged TRAM esophagectomy group
Arm Type
Experimental
Arm Description
Patients with malignant esophagus neoplasms randomized to Supercharged TRAM esophagectomy will undergo to esophagectomy, immediately followed by supercharged esophagogastroplasty.
Intervention Type
Procedure
Intervention Name(s)
Supercharged TRAM esophagectomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional Esophagectomy
Intervention Description
Esophagectomy, immediately followed by an esophagus reconstruction trough esophagogastroplasty.
Primary Outcome Measure Information:
Title
Presence and number of post-operatory complications
Description
surgical wound infection, hematoma, anastomotic leakage, stenosis, chylothorax and clinical complications due to hospitalization
Time Frame
Until 1 year after Surgery
Title
Mortality
Description
Patients who and when died
Time Frame
Until 1 year after surgery after surgery
Secondary Outcome Measure Information:
Title
Days in intensive care unit
Description
Number of days patient will stay at intensive care unit
Time Frame
From the surgery day until the date patient leave intensive care unit
Title
Hospitalization period
Description
Number of days patient will stay in hospital after surgery
Time Frame
From the surgery day until the date patient leave hospital
Title
Need of vasoactive drugs
Description
If patient use vasoactive drugs drugs hospitalization
Time Frame
From the surgery day until the date patient leave hospital
Title
Blood transfusion need
Description
If patients need blood transfusion during hospitalization
Time Frame
From the surgery day until the date patient leave hospital
Title
Drain use time
Description
How long patient use drain
Time Frame
From the surgery day until the date patient took off drain

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of esophageal malignancy cancer; Ability to understand and collaborate during treatment; Exclusion Criteria: Previous gastrectomy; Previous abdominal surgery with risk of altering stomach vascularization; Previous head and neck surgery with risk of alteration of cervical vessels.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Flavio Takeda, PhD, MD
Phone
+55 11 999079973
Email
flavio.takeda@hc.fm.usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flavio Takeda, PhD, MD
Organizational Affiliation
Instituto do Cancer do Estado de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto do Cancer do Estado de São Paulo (ICESP)
City
São Paulo
State/Province
SP
ZIP/Postal Code
01246000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flavio Takeda, MD
First Name & Middle Initial & Last Name & Degree
Flavio Takeda, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
6987040
Citation
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.
Results Reference
background
PubMed Identifier
718285
Citation
Akiyama 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.
Results Reference
background
PubMed Identifier
21200211
Citation
Barzin 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.
Results Reference
background
PubMed Identifier
8903814
Citation
Bourke 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.
Results Reference
background
PubMed Identifier
15051003
Citation
Briel 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.
Results Reference
background
PubMed Identifier
11465183
Citation
Buskens 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.
Results Reference
background
PubMed Identifier
7646084
Citation
Collard 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.
Results Reference
background
PubMed Identifier
10967750
Citation
D'Amico TA, Harpole DH Jr. Molecular biology of esophageal cancer. Chest Surg Clin N Am. 2000 Aug;10(3):451-69.
Results Reference
background
PubMed Identifier
26185366
Citation
Domper 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.
Results Reference
background
PubMed Identifier
9774004
Citation
Edsander-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.
Results Reference
background
PubMed Identifier
12351972
Citation
El-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.
Results Reference
background
PubMed Identifier
8783767
Citation
Ferguson A, Kingstone K. Coeliac disease and malignancies. Acta Paediatr Suppl. 1996 May;412:78-81. doi: 10.1111/j.1651-2227.1996.tb14259.x.
Results Reference
background
PubMed Identifier
25220842
Citation
Ferlay 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.
Results Reference
background
PubMed Identifier
29932372
Citation
Garcia-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.
Results Reference
background
PubMed Identifier
18872828
Citation
GARLOCK JH. Resection of thoracic esophagus for carcinoma located above arch of aorta; cervical esophagogastrostomy. Surgery. 1948 Jul;24(1):1-8. No abstract available.
Results Reference
background
PubMed Identifier
20275212
Citation
GARLOCK JH. Combined abdominothoracic approach for carcinoma of cardia and lower esophagus. Surg Gynecol Obstet. 1946 Dec;83(6):737-41. No abstract available.
Results Reference
background
PubMed Identifier
16651940
Citation
Garvey PB, Buchel EW, Pockaj BA, Casey WJ 3rd, Gray RJ, Hernandez JL, Samson TD. DIEP and pedicled TRAM flaps: a comparison of outcomes. Plast Reconstr Surg. 2006 May;117(6):1711-9; discussion 1720-1. doi: 10.1097/01.prs.0000210679.77449.7d.
Results Reference
background
PubMed Identifier
5306651
Citation
Goffi FS, Bevilacqua RG, Ferreira EA, Silva PA, Pinheiro Y, Lima EW, Bastos Eda S. [Surgery of cancer of he esophagus. Technic and results]. AMB Rev Assoc Med Bras. 1969 Jan;15(1):37-42. No abstract available. Portuguese.
Results Reference
background
PubMed Identifier
11578290
Citation
Griffin SM, Lamb PJ, Dresner SM, Richardson DL, Hayes N. Diagnosis and management of a mediastinal leak following radical oesophagectomy. Br J Surg. 2001 Oct;88(10):1346-51. doi: 10.1046/j.0007-1323.2001.01918.x.
Results Reference
background
PubMed Identifier
12968954
Citation
Grotting JC, Beckenstein MS, Arkoulakis NS. The art and science of autologous breast reconstruction. Breast J. 2003 Sep-Oct;9(5):350-60. doi: 10.1046/j.1524-4741.2003.09527.x.
Results Reference
background
PubMed Identifier
2957016
Citation
Harashina T, Sone K, Inoue T, Fukuzumi S, Enomoto K. Augmentation of circulation of pedicled transverse rectus abdominis musculocutaneous flaps by microvascular surgery. Br J Plast Surg. 1987 Jul;40(4):367-70. doi: 10.1016/0007-1226(87)90039-7.
Results Reference
background
PubMed Identifier
7071252
Citation
Scheflan M, Hartrampf CR, Black PW. Breast reconstruction with a transverse abdominal island flap. Plast Reconstr Surg. 1982 May;69(5):908-9. No abstract available.
Results Reference
background
PubMed Identifier
998871
Citation
Hermreck AS, Crawford DG. The esophageal anastomotic leak. Am J Surg. 1976 Dec;132(6):794-8. doi: 10.1016/0002-9610(76)90461-x.
Results Reference
background
PubMed Identifier
396670
Citation
Holmstrom H. The free abdominoplasty flap and its use in breast reconstruction. An experimental study and clinical case report. Scand J Plast Reconstr Surg. 1979;13(3):423-27. doi: 10.3109/02844317909013092.
Results Reference
background
PubMed Identifier
24075499
Citation
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.
Results Reference
background
PubMed Identifier
23434255
Citation
Kesler KA, Pillai ST, Birdas TJ, Rieger KM, Okereke IC, Ceppa D, Socas J, Starnes SL. "Supercharged" isoperistaltic colon interposition for long-segment esophageal reconstruction. Ann Thorac Surg. 2013 Apr;95(4):1162-8; discussion 1168-9. doi: 10.1016/j.athoracsur.2013.01.006. Epub 2013 Feb 21.
Results Reference
background
PubMed Identifier
17721210
Citation
Kim EK, Lee TJ, Eom JS. Comparison of fat necrosis between zone II and zone III in pedicled transverse rectus abdominis musculocutaneous flaps: a prospective study of 400 consecutive cases. Ann Plast Surg. 2007 Sep;59(3):256-9. doi: 10.1097/01.sap.0000252770.15946.14.
Results Reference
background
PubMed Identifier
11553820
Citation
Kim SH, Lee KS, Shim YM, Kim K, Yang PS, Kim TS. Esophageal resection: indications, techniques, and radiologic assessment. Radiographics. 2001 Sep-Oct;21(5):1119-37; discussion 1138-40. doi: 10.1148/radiographics.21.5.g01se031119.
Results Reference
background
PubMed Identifier
14765307
Citation
Koop H. Gastroesophageal reflux disease and Barrett's esophagus. Endoscopy. 2004 Feb;36(2):103-9. doi: 10.1055/s-2004-814177.
Results Reference
background
PubMed Identifier
9924407
Citation
Kroll SS. Bilateral breast reconstruction in very thin patients with extended free TRAM flaps. Br J Plast Surg. 1998 Oct;51(7):535-7. doi: 10.1054/bjps.1998.0014.
Results Reference
background
PubMed Identifier
10080844
Citation
Lagergren J, Bergstrom R, Lindgren A, Nyren O. Symptomatic gastroesophageal reflux as a risk factor for esophageal adenocarcinoma. N Engl J Med. 1999 Mar 18;340(11):825-31. doi: 10.1056/NEJM199903183401101.
Results Reference
background
PubMed Identifier
10375336
Citation
Lagergren J, Bergstrom R, Nyren O. Association between body mass and adenocarcinoma of the esophagus and gastric cardia. Ann Intern Med. 1999 Jun 1;130(11):883-90. doi: 10.7326/0003-4819-130-11-199906010-00003.
Results Reference
background
PubMed Identifier
11301408
Citation
van Lanschot JJ, Hulscher JB, Buskens CJ, Tilanus HW, ten Kate FJ, Obertop H. Hospital volume and hospital mortality for esophagectomy. Cancer. 2001 Apr 15;91(8):1574-8. doi: 10.1002/1097-0142(20010415)91:83.0.co;2-2.
Results Reference
background
PubMed Identifier
20249263
Citation
LONGMIRE WP Jr. A modification of the Roux technique for antethoracic esophageal reconstruction. Surgery. 1947 Jul;22(1):94-100. No abstract available.
Results Reference
background
PubMed Identifier
9379884
Citation
Marck KW, van der Biezen JJ, Dol JA. Internal mammary artery and vein supercharge in TRAM flap breast reconstruction. Microsurgery. 1996;17(7):371-4. doi: 10.1002/(SICI)1098-2752(1996)17:73.0.CO;2-J.
Results Reference
background
PubMed Identifier
1449294
Citation
Liebermann-Meffert DM, Meier R, Siewert JR. Vascular anatomy of the gastric tube used for esophageal reconstruction. Ann Thorac Surg. 1992 Dec;54(6):1110-5. doi: 10.1016/0003-4975(92)90077-h.
Results Reference
background
PubMed Identifier
8248411
Citation
Morris SF, Taylor GI. Predicting the survival of experimental skin flaps with a knowledge of the vascular architecture. Plast Reconstr Surg. 1993 Dec;92(7):1352-61.
Results Reference
background
PubMed Identifier
13659330
Citation
NAKAYAMA K. Statistical review of five-year survivals after surgery for carcinoma of the esophagus and cardiac portion of the stomach. Surgery. 1959 Jun;45(6):883-9. No abstract available.
Results Reference
background
PubMed Identifier
11722100
Citation
Molina-Navarro C, Hosking SW, Hayward SJ, Flowerdew AD. Gastroaortic fistula as an early complication of esophagectomy. Ann Thorac Surg. 2001 Nov;72(5):1783-8. doi: 10.1016/s0003-4975(00)02569-8.
Results Reference
background
PubMed Identifier
2059779
Citation
Pernia LR, Miller HL, Saltz R, Vasconez LO. "Supercharging" the rectus abdominis muscle to provide a single flap for cover of large mediastinal wound defects. Br J Plast Surg. 1991 May-Jun;44(4):243-6. doi: 10.1016/0007-1226(91)90064-q.
Results Reference
background
PubMed Identifier
18431046
Citation
Rezai M, Darsow M, Kummel S, Kramer S. Autologous and alloplastic breast reconstruction--overview of techniques, indications and results. Gynakol Geburtshilfliche Rundsch. 2008;48(2):68-75. doi: 10.1159/000118934. Epub 2008 Apr 16.
Results Reference
background
PubMed Identifier
17061276
Citation
Serletti JM. Breast reconstruction with the TRAM flap: pedicled and free. J Surg Oncol. 2006 Nov 1;94(6):532-7. doi: 10.1002/jso.20492.
Results Reference
background
PubMed Identifier
9280083
Citation
Urschel JD. Ischemic conditioning of the stomach may reduce the incidence of esophagogastric anastomotic leaks complicating esophagectomy: a hypothesis. Dis Esophagus. 1997 Jul;10(3):217-9. doi: 10.1093/dote/10.3.217.
Results Reference
background
PubMed Identifier
8784400
Citation
Valverde A, Hay JM, Fingerhut A, Elhadad A. Manual versus mechanical esophagogastric anastomosis after resection for carcinoma: a controlled trial. French Associations for Surgical Research. Surgery. 1996 Sep;120(3):476-83. doi: 10.1016/s0039-6060(96)80066-3.
Results Reference
background
PubMed Identifier
11224620
Citation
Whooley BP, Law S, Murthy SC, Alexandrou A, Wong J. Analysis of reduced death and complication rates after esophageal resection. Ann Surg. 2001 Mar;233(3):338-44. doi: 10.1097/00000658-200103000-00006.
Results Reference
background
PubMed Identifier
8532809
Citation
Yamamoto Y, Nohira K, Sugihara T, Shintomi Y, Ohura T. Superiority of the microvascularly augmented flap: analysis of 50 transverse rectus abdominis myocutaneous flaps for breast reconstruction. Plast Reconstr Surg. 1996 Jan;97(1):79-83; discussion 84-5. doi: 10.1097/00006534-199601000-00013.
Results Reference
background

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Supercharged TRAM Evaluation in Cervical Esophagogastroplasty After Esophagectomy

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