Stomach Neoplasms3DINGCRSNCT03599895
Application of 3D Printing Technique in Radical Gastrectomy With Leonardo da Vinci Robot
A study testing 3D printing model and non 3D printing model in people with Stomach Neoplasms, run by First Affiliated Hospital Xi'an Jiaotong University.
Trial summary
The incidence of gastric cancer is the highest in China, and surgery is one of the most effective treatment methods. Da Vinci robot radical gastrectomy for gastric cancer has the advantage of minimally invasive and fine operation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- 3D printing model and non 3D printing model
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2018to 30 Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients without contraindications gastroscope，surgery and anesthesia;
- There is no history of abdominal surgery, no severe abdominal cavity adhesion;
- Not found the tumor metastasis;
- Normal coagulation function;
- There is no history of anticoagulant drugs, or who take aspirin, salvia miltiorrhiza, etc., should stop taking drugs for more than one week;
- Patients and their families volunteered choice the surgical procedure and signed informed consent.
Who cannot join
- Patients with preoperative assessment of distant metastasis;
- Patients with preoperative radiation and chemotherapy or hormone therapy;
- Patients with acute obstruction, bleeding or perforation of the emergency surgery;
- Patients with a history of abdominal trauma or abdominal surgery;
- Patients with contraindications gastroscope，surgery and anesthesia.
About this study
Official title: Combined Application of 3D Printing Technology and Robotic Surgery in Radical Gastrectomy of Gastric Cancer
The incidence of gastric cancer is the highest in China, and surgery is one of the most effective treatment methods. Da Vinci robot radical gastrectomy for gastric cancer has the advantage of minimally invasive and fine operation. However, due to complicated perigastric anatomy, abundant blood supply and wide distribution of lymph nodes, it is widely used in clinical use of .Combine the 3D printing technique with imaging examination (digestive endoscopy,3Dct cta/ctv, etc.) ,making the 3D model of da Vinci robot assisted radical gastrectomy can fully show the anatomical relationship around gastric cancer, determine the flow and variation of splenic portal vessels, and the distribution of splenic hilar lymph nodes. In order to eliminate the imagination difference of spatial anatomical structure before operation, it is easier for surgeons to optimize the operation plan, to control the operation process and to improve the accuracy, and to adopt individualized operation suitable for the patients.
Read the detailed description
The investigators will work with general surgery, imaging department and 3D printing center to try to print gastric cancer model and guide the operation. After obtaining the approval of the Hospital Ethics Committee, 20 patients with gastric cancer were collected for imaging examination and evaluation, and the normal physical model of 70% normal volume was printed with Guang Min resin material.The investigators will analyse the anatomical relationship between the tumor and surrounding tissues,and determine the range of tumor excision and the feasibility and safety of radical gastrectomy with Leonardo da Vinci robot for gastric cancer.Through the assistance of the 3D model,The investigators will select the suitable operation path to determine the extent of tumor excision and lymph node dissection.Furthermore, 3D print model is used to provide real-time navigation for key steps of surgery. The purpose of this research is to observe the application value of 3D printing technique in gastric cancer laparoscopic surgery with Leonardo da Vinci robot radical gastrectomy, and to provide reference for the development of 3D printing model of other complicated digestive tract surgery.
- Conditions
- Stomach Neoplasms
- Being tested
- 3D printing model, non 3D printing model
- Keywords
- 3D printing technology
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printing modelProcedure or surgery
Combine the 3D printing technique with imaging examination ,making the 3D model of da Vinci robot assisted radical gastrectomy
non 3D printing modelProcedure or surgery
da Vinci robot assisted radical gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| 3D printing group | Experimental | the radical gastrectomy for gastric cancer of Davinci robotic surgery with the assistance of 3D printing model Receives: Procedure: 3D printing model |
| non 3D printing group | Experimental | the radical gastrectomy for gastric cancer of Davinci robotic surgery without the assistance of 3D printing model Receives: Procedure: non 3D printing model |
What is being measured
The primary outcome is the main question the study is designed to answer.
operation time
record in minutes,from the beginning of anesthesia to the end
Measured: 1 hours to 6 hours through the surgery completion
Secondary outcomes (7)
blood loss
from the surgical record sheet
Measured: 1 hours to 6 hours through the surgery completion
success rate
the time in bed to the postoperative patient
Measured: from two days to two weeks after surgery
time in bed
the time in bed to the postoperative patient
Measured: from two days to two weeks after surgery
time to take food
the time to eat to the postoperative patient
Measured: from two days to two weeks after surgery
postoperative complication rate
including anastomotic stoma fistula,anastomotic stenosis,abdominal
Measured: from two weeks to one year after surgery
tumor recurrence rate
periodic review the CT or MRI or endoscope
Measured: from one month to 2 years after surgery
hospitalization expenses
total hospitalization expenses
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Aug 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion30 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599895
- Sponsor's protocol ID
- XJTU1AF-3D-2017-006
- Acronym
- 3DINGCRS
- Status last verified
- Jul 2018
- First submitted
- 17 Jul 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Application of 3D Printing Technology and Robotic Surgery in Radical Gastrectomy of Gastric Cancer
- ClinicalTrials.gov ID
- NCT03599895
- Acronym / sponsor ID
- 3DINGCRS / XJTU1AF-3D-2017-006
- Conditions
- Stomach Neoplasms
- Keywords
- 3D printing technology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 30 Mar 2020 (estimated)
- First posted
- 26 Jul 2018 (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.
The incidence of gastric cancer is the highest in China, and surgery is one of the most effective treatment methods. Da Vinci robot radical gastrectomy for gastric cancer has the advantage of minimally invasive and fine operation. However, due to complicated perigastric anatomy, abundant blood supply and wide distribution of lymph nodes, it is widely used in clinical use of .Combine the 3D printing technique with imaging examination (digestive endoscopy,3Dct cta/ctv, etc.) ,making the 3D model of da Vinci robot assisted radical gastrectomy can fully show the anatomical relationship around gastric cancer, determine the flow and variation of splenic portal vessels, and the distribution of splenic hilar lymph nodes. In order to eliminate the imagination difference of spatial anatomical structure before operation, it is easier for surgeons to optimize the operation plan, to control the operation process and to improve the accuracy, and to adopt individualized operation suitable for the patients.
Detailed description
The investigators will work with general surgery, imaging department and 3D printing center to try to print gastric cancer model and guide the operation. After obtaining the approval of the Hospital Ethics Committee, 20 patients with gastric cancer were collected for imaging examination and evaluation, and the normal physical model of 70% normal volume was printed with Guang Min resin material.The investigators will analyse the anatomical relationship between the tumor and surrounding tissues,and determine the range of tumor excision and the feasibility and safety of radical gastrectomy with Leonardo da Vinci robot for gastric cancer.Through the assistance of the 3D model,The investigators will select the suitable operation path to determine the extent of tumor excision and lymph node dissection.Furthermore, 3D print model is used to provide real-time navigation for key steps of surgery. The purpose of this research is to observe the application value of 3D printing technique in gastric cancer laparoscopic surgery with Leonardo da Vinci robot radical gastrectomy, and to provide reference for the development of 3D printing model of other complicated digestive tract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D printing group | Experimental | Procedure: 3D printing modelthe radical gastrectomy for gastric cancer of Davinci robotic surgery with the assistance of 3D printing model |
| non 3D printing group | Experimental | Procedure: non 3D printing modelthe radical gastrectomy for gastric cancer of Davinci robotic surgery without the assistance of 3D printing model |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients without contraindications gastroscope，surgery and anesthesia;
- There is no history of abdominal surgery, no severe abdominal cavity adhesion;
- Not found the tumor metastasis;
- Normal coagulation function;
- There is no history of anticoagulant drugs, or who take aspirin, salvia miltiorrhiza, etc., should stop taking drugs for more than one week;
Key exclusion criteria (5 listed)
- Patients with preoperative assessment of distant metastasis;
- Patients with preoperative radiation and chemotherapy or hormone therapy;
- Patients with acute obstruction, bleeding or perforation of the emergency surgery;
- Patients with a history of abdominal trauma or abdominal surgery;
- Patients with contraindications gastroscope，surgery and anesthesia.
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 |
|---|---|---|
| 3D printing modelCombine the 3D printing technique with imaging examination ,making the 3D model of da Vinci robot assisted radical gastrectomy | Procedure or surgery | 3D printing group |
| non 3D printing modelda Vinci robot assisted radical gastrectomy | Procedure or surgery | non 3D printing group |
Primary outcome
operation time
Time frame: 1 hours to 6 hours through the surgery completion
record in minutes,from the beginning of anesthesia to the end
7 secondary outcomes
blood loss
Time frame: 1 hours to 6 hours through the surgery completion
success rate
Time frame: from two days to two weeks after surgery
time in bed
Time frame: from two days to two weeks after surgery
time to take food
Time frame: from two days to two weeks after surgery
postoperative complication rate
Time frame: from two weeks to one year after surgery
tumor recurrence rate
Time frame: from one month to 2 years after surgery
hospitalization expenses
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printing model and non 3D printing model in people with Stomach Neoplasms, run by First Affiliated Hospital Xi'an Jiaotong University.
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 6 inclusion and 5 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 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
operation time (time frame: 1 hours to 6 hours through the surgery completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2018.