Esophageal CancerNCT02292914
Prospective Analysis of Robot-Assisted Surgery
A study testing Robot-assisted surgery and Conventional Surgery in people with Esophageal Cancer and Gastric Cancer, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial summary
The robot-assisted surgery allows three-dimensional view, detailed access of small structures, depth perception and articulated movements with wide latitude. Thinking about the inclusion of this branch of surgical outcome ICESP encouraged the training of their doctors and other health professionals , and has three… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer, Gastric Cancer, Pancreatic Cancer
- What is being tested?
- Robot-assisted surgery and Conventional Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,120 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Mar 2014to 10 Jul 2020
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients eligible for robotic-assisted surgery
Who cannot join
- Pregnant patients
- Patients with decompensated systemic diseases
- Patients who were unfit for general anesthesia
- Patients without an indication for surgical treatment of cancer
Trial locations and contacts
1 site in 1 country.
Ivan Cecconello, MD contact
Ulysses Ribeiro-Junior, MD contact
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Câncer de São Paulo - ICESP
São Paulo
Ivan Cecconello, MD, icecconello@hotmail.com
Silvia Kobayashi, MD, silvia@kobayashi@icesp.org.br
About this study
The robot-assisted surgery allows three-dimensional view, detailed access of small structures, depth perception and articulated movements with wide latitude. Thinking about the inclusion of this branch of surgical outcome ICESP encouraged the training of their doctors and other health professionals , and has three tutors in the area of robot- assisted laparoscopic surgery , and various medical clinical staff , already trained , and already perform the procedure in other centers . The da Vinci ® Surgical System ( only existing in the World market) , consisting of one or two consoles for the surgeon and a tutor if necessary was adopted. Ergonomically designed, a stand next to the patient , with four interactive robotic arms , one of them , a vision system for high performance and the other three for exclusive EndoWrist ® instruments . Driven by the latest robotic technology , computer programs , frictionless transmission of manual controls , movements in scale and filtered made by the surgeon in the da Vinci ® System console are translated into precise movements of the instruments EndoWrist ® For surgeons , the da Vinci ® System offers superior 3D viewing with larger surgical precision ergonomic comfort and dexterity . For hospitals , the da Vinci ® Surgical System enables clinical and economic benefits of minimally invasive surgery are applied to a broader base of patients cirúrgicos.The main objective is to evaluate the safety and effectiveness of robotic surgery in the surgical treatment of cancer in operations below, as their specialties : Digestive , Urology , Gynecology , Head and Neck and Thorax . This is a prospective study lasting 36 months , where 1120 patients with surgical diseases in programming for the following operations will be studied : transthoracic esophagectomy ; subtotal gastrectomy with lymphadenectomy ; partial pancreatectomy ; resection of the rectum ; prostatectomy ; cystectomy ; partial nephrectomy ; hysterectomy with or without pelvic and paraaortic lymphadenectomy ; resection of malignant tumors of the mouth and orofaringolaringe and lung lobectomy . Patients will come from the outpatient services of the Institute of Cancer of São Paulo - ICESP
Read the detailed description
This is a prospective study lasting 36 months. This project includes 10 subprojects in five different specialties:
Specialty: Surgery of the Digestive System Subproject 1: trans-thoracic esophagectomy Subproject 2: subtotal gastrectomy with lymphadenectomy Subproject 3: partial pancreatectomy Subproject 4: resection of the rectum Specialty: Urology Surgery Subproject 5: cystectomy Subproject 6: Prostatectomy Subproject 7: Partial Nephrectomy Specialty: Gynecological Surgery Activity 8: Hysterectomy with or without pelvic lymphadenectomy and paraaortic Specialty: Head and Neck Surgery Activity 9: resection of malignant tumors of the mouth and orofaringolaringe Specialty: Thoracic Surgery Subproject 10: pulmonary lobectomies
Each subproject will have a study design, inclusion criteria, exclusion criteria and specific methodologies.
- Conditions
- Esophageal Cancer, Gastric Cancer, Pancreatic Cancer, Rectal Cancer, Bladder Cancer, Prostate Cancer
- Being tested
- Robot-assisted surgery, Conventional Surgery
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Rectal Neoplasms, Urinary Bladder Neoplasms, Prostatic Neoplasms, Kidney Neoplasms, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted surgeryProcedure or surgery
Robot-assisted esophagectomy; Robot-assisted subtotal gastrectomy; Robot-assisted pancreatectomy;Robot-assisted rectal resection; Robot-assisted radical cistectomy;Robot-assisted prostatectomy;Robot-assisted Partial Nephrectomy; Robot-assisted hysterectomy;Robot-assisted Resection of malignant tumors of the mouth and orofaringolaringe; Robot-assisted lung lobectomy
Conventional SurgeryProcedure or surgery
Thoracoscopic Esophagectomy; Open rectal resection and rectal laparoscopy resection; Open radical cistectomy; Open prostatectomy; Open Partial Nephrectomy; Laparoscopic hysterectomy; Laparoscopic lung lobectomy
| Study group | Role | What they receive |
|---|---|---|
| Robot-Assisted Surgery | Experimental | patients undergoing robot assisted surgery for the treatment of cancer Receives: Procedure: Robot-assisted surgery |
| Conventional Surgery | Active comparator | patients undergoing conventional surgery for the treatment of cancer Receives: Procedure: Conventional Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Complications
The postoperative complications will be mesured by clavien-dindo scale
Measured: 30 days
Secondary outcomes (1)
ICU and hospital length of stay
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study start10 Mar 2014
- Primary completion10 Jul 2020 (estimated)
- Study completion10 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Esophageal 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
- 1,120 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
- Ivan Cecconello, MD, Principal investigator, Faculdade de Medicina da USPUlysses Ribeiro-Junior, MD, Principal investigator, Faculdade de Medicina da USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292914
- Sponsor's protocol ID
- NP433/13
- Status last verified
- Aug 2019
- First submitted
- 3 Sep 2014
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Abdalla RZ, Nahas WC, Cecconello I, Ribeiro U Jr. Prospective study of a structured robotic surgery training program in a public cancer hospital in Brazil. J Robot Surg. 2025 Oct 16;19(1):695. doi: 10.1007/s11701-025-02881-6.
PubMed 41099765Nahas WC, Rodrigues GJ, Rodrigues Goncalves FA, Sawczyn GV, Barros GG, Cardili L, Guglielmetti GB, Fazoli AJC, Cordeiro MD, Cassao VDA, Chade DC, Neves De Oliveira LC, Murta CB, Pontes Junior J, Trindade EM, Bastos DA, Sarkis AS, Mitre AI, Trinh QD, Coelho RF. Perioperative, Oncological, and Functional Outcomes Between Robot-Assisted Laparoscopic Prostatectomy and Open Radical Retropubic Prostatectomy: A Randomized Clinical Trial. J Urol. 2024 Jul;212(1):32-40. doi: 10.1097/JU.0000000000003967. Epub 2024 May 9.
PubMed 38723593Ribeiro U Jr, Dias AR, Ramos MFKP, Yagi OK, Oliveira RJ, Pereira MA, Abdalla RZ, Zilberstein B, Nahas SC, Cecconello I. Short-Term Surgical Outcomes of Robotic Gastrectomy Compared to Open Gastrectomy for Patients with Gastric Cancer: a Randomized Trial. J Gastrointest Surg. 2022 Dec;26(12):2477-2485. doi: 10.1007/s11605-022-05448-0. Epub 2022 Sep 20.
PubMed 36127557Terra RM, Araujo PHXN, Lauricella LL, Campos JRM, Trindade JRM, Pego-Fernandes PM. A Brazilian randomized study: Robotic-Assisted vs. Video-assisted lung lobectomy Outcomes (BRAVO trial). J Bras Pneumol. 2022 Jul 8;48(4):e20210464. doi: 10.36416/1806-3756/e20210464. eCollection 2022.
PubMed 35830078
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of Robot-Assisted Surgery
- ClinicalTrials.gov ID
- NCT02292914
- Acronym / sponsor ID
- NP433/13
- Conditions
- Esophageal Cancer, Gastric Cancer, Pancreatic Cancer, Rectal Cancer, Bladder Cancer, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,120 participants (estimated)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- 10 Mar 2014
- Primary completion
- 10 Jul 2020 (estimated)
- Study completion
- 10 Jul 2020 (estimated)
- First posted
- 18 Nov 2014 (estimated)
- 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.
The robot-assisted surgery allows three-dimensional view, detailed access of small structures, depth perception and articulated movements with wide latitude. Thinking about the inclusion of this branch of surgical outcome ICESP encouraged the training of their doctors and other health professionals , and has three tutors in the area of robot- assisted laparoscopic surgery , and various medical clinical staff , already trained , and already perform the procedure in other centers . The da Vinci ® Surgical System ( only existing in the World market) , consisting of one or two consoles for the surgeon and a tutor if necessary was adopted. Ergonomically designed, a stand next to the patient , with four interactive robotic arms , one of them , a vision system for high performance and the other three for exclusive EndoWrist ® instruments . Driven by the latest robotic technology , computer programs , frictionless transmission of manual controls , movements in scale and filtered made by the surgeon in the da Vinci ® System console are translated into precise movements of the instruments EndoWrist ® For surgeons , the da Vinci ® System offers superior 3D viewing with larger surgical precision ergonomic comfort and dexterity . For hospitals , the da Vinci ® Surgical System enables clinical and economic benefits of minimally invasive surgery are applied to a broader base of patients cirúrgicos.The main objective is to evaluate the safety and effectiveness of robotic surgery in the surgical treatment of cancer in operations below, as their specialties : Digestive , Urology , Gynecology , Head and Neck and Thorax . This is a prospective study lasting 36 months , where 1120 patients with surgical diseases in programming for the following operations will be studied : transthoracic esophagectomy ; subtotal gastrectomy with lymphadenectomy ; partial pancreatectomy ; resection of the rectum ; prostatectomy ; cystectomy ; partial nephrectomy ; hysterectomy with or without pelvic and paraaortic lymphadenectomy ; resection of malignant tumors of the mouth and orofaringolaringe and lung lobectomy . Patients will come from the outpatient services of the Institute of Cancer of São Paulo - ICESP
Detailed description
This is a prospective study lasting 36 months. This project includes 10 subprojects in five different specialties:
Specialty: Surgery of the Digestive System Subproject 1: trans-thoracic esophagectomy Subproject 2: subtotal gastrectomy with lymphadenectomy Subproject 3: partial pancreatectomy Subproject 4: resection of the rectum Specialty: Urology Surgery Subproject 5: cystectomy Subproject 6: Prostatectomy Subproject 7: Partial Nephrectomy Specialty: Gynecological Surgery Activity 8: Hysterectomy with or without pelvic lymphadenectomy and paraaortic Specialty: Head and Neck Surgery Activity 9: resection of malignant tumors of the mouth and orofaringolaringe Specialty: Thoracic Surgery Subproject 10: pulmonary lobectomies
Each subproject will have a study design, inclusion criteria, exclusion criteria and specific methodologies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-Assisted Surgery | Experimental | Procedure: Robot-assisted surgerypatients undergoing robot assisted surgery for the treatment of cancer |
| Conventional Surgery | Active comparator | Procedure: Conventional Surgerypatients undergoing conventional surgery for the treatment of cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients eligible for robotic-assisted surgery
Key exclusion criteria (4 listed)
- Pregnant patients
- Patients with decompensated systemic diseases
- Patients who were unfit for general anesthesia
- Patients without an indication for surgical treatment of cancer
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 |
|---|---|---|
| Robot-assisted surgeryRobot-assisted esophagectomy; Robot-assisted subtotal gastrectomy; Robot-assisted pancreatectomy;Robot-assisted rectal resection; Robot-assisted radical cistectomy;Robot-assisted prostatectomy;Robot-assisted Partial Nephrectomy; Robot-assisted hysterectomy;Robot-assisted Resection of malignant tumors of the mouth and orofaringolaringe; Robot-assisted lung lobectomy | Procedure or surgery | Robot-Assisted Surgery |
| Conventional SurgeryThoracoscopic Esophagectomy; Open rectal resection and rectal laparoscopy resection; Open radical cistectomy; Open prostatectomy; Open Partial Nephrectomy; Laparoscopic hysterectomy; Laparoscopic lung lobectomy | Procedure or surgery | Conventional Surgery |
Primary outcome
Postoperative Complications
Time frame: 30 days
The postoperative complications will be mesured by clavien-dindo scale
1 secondary outcome
ICU and hospital length of stay
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Derived from this study: PubMed 41099765Abdalla RZ, Nahas WC, Cecconello I, Ribeiro U Jr. Prospective study of a structured robotic surgery training program in a public cancer hospital in Brazil. J Robot Surg. 2025 Oct 16;19(1):695. doi: 10.1007/s11701-025-02881-6.
- Derived from this study: PubMed 38723593Nahas WC, Rodrigues GJ, Rodrigues Goncalves FA, Sawczyn GV, Barros GG, Cardili L, Guglielmetti GB, Fazoli AJC, Cordeiro MD, Cassao VDA, Chade DC, Neves De Oliveira LC, Murta CB, Pontes Junior J, Trindade EM, Bastos DA, Sarkis AS, Mitre AI, Trinh QD, Coelho RF. Perioperative, Oncological, and Functional Outcomes Between Robot-Assisted Laparoscopic Prostatectomy and Open Radical Retropubic Prostatectomy: A Randomized Clinical Trial. J Urol. 2024 Jul;212(1):32-40. doi: 10.1097/JU.0000000000003967. Epub 2024 May 9.
- Derived from this study: PubMed 36127557Ribeiro U Jr, Dias AR, Ramos MFKP, Yagi OK, Oliveira RJ, Pereira MA, Abdalla RZ, Zilberstein B, Nahas SC, Cecconello I. Short-Term Surgical Outcomes of Robotic Gastrectomy Compared to Open Gastrectomy for Patients with Gastric Cancer: a Randomized Trial. J Gastrointest Surg. 2022 Dec;26(12):2477-2485. doi: 10.1007/s11605-022-05448-0. Epub 2022 Sep 20.
- Derived from this study: PubMed 35830078Terra RM, Araujo PHXN, Lauricella LL, Campos JRM, Trindade JRM, Pego-Fernandes PM. A Brazilian randomized study: Robotic-Assisted vs. Video-assisted lung lobectomy Outcomes (BRAVO trial). J Bras Pneumol. 2022 Jul 8;48(4):e20210464. doi: 10.36416/1806-3756/e20210464. eCollection 2022.
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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.
Ivan Cecconello, MD contact
Ulysses Ribeiro-Junior, MD contact
Ivan Cecconello, MD principal investigator
Faculdade de Medicina da USP
Ulysses Ribeiro-Junior, MD principal investigator
Faculdade de Medicina da USP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted surgery and Conventional Surgery in people with Esophageal Cancer and Gastric Cancer, 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 1 inclusion and 4 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 8 Aug 2019. 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 Ivan Cecconello, MD (icecconello@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Complications (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 NCT02292914, which also lists 4 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 8 Aug 2019.