Stomach NeoplasmsNCT07034495
Laparotomy, Laparoscopy, da Vinci System
An observational study of Stomach Neoplasms and Pancreatic Neoplasms, run by National Chung Hsing University at 1 site in Taiwan.
Trial summary
1. This study looks at whether newer surgical tools-like the da Vinci robotic system-can help patients recover better after major abdominal surgeries. It compares three surgery methods: traditional open surgery, standard laparoscopic (minimally invasive) surgery, and robotic surgery. 2. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stomach Neoplasms, Pancreatic Neoplasms, Liver Neoplasms
- How many people
- 486 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2015to 30 Sep 2019
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A population that needs robotic surgery for gastrectomy, liver resection, or pancreatectomy
Who may be able to join
- Adult patients (age ≥ 18 years)
- Underwent one of the following surgeries: gastrectomy, liver resection, or pancreatectomy
- Received surgery at Chung Shan Medical University Hospital between July 2015 and September 2019
- Surgery performed by the general surgery team with experience in open, laparoscopic, and robotic (da Vinci) surgery
- Surgical method included one of the following: open surgery (laparotomy), laparoscopic surgery, or robotic (da Vinci) surgery
Who cannot join
- Patients who underwent surgeries outside the specified types (i.e., not gastrectomy, liver resection, or pancreatectomy)
- Patients with incomplete or missing perioperative data (e.g., operative time, blood loss, or hospital stay)
- Patients who underwent combined or staged surgical procedures unrelated to the HPB domain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing of Laparotomy, Laparoscopy, and daVinci in Whipple, Hepatectomy, Pancreatectomy, and Gastrectomy
- This study looks at whether newer surgical tools-like the da Vinci robotic system-can help patients recover better after major abdominal surgeries. It compares three surgery methods: traditional open surgery, standard laparoscopic (minimally invasive) surgery, and robotic surgery.
- The research focused on four common operations: Stomach surgery (gastrectomy), Pancreas surgery (pancreatectomy), Liver surgery (hepatectomy) and andWhipple procedure
- Researchers looked at medical records from 486 patients over five years. They compared how long each surgery took, how much blood was lost, and how many days patients stayed in the hospital.
- The study wanted to see if robotic and laparoscopic surgeries help patients by making the surgery faster, safer, and with a quicker recovery.
- The benefits depended on the type of surgery. In many cases, robotic and laparoscopic surgery led to shorter hospital stays, less bleeding, or faster surgeries. These results suggest that using newer technology can help make surgeries safer and recovery easier for patients.
Read the detailed description
- The study was conducted with the assistance of Chung Shan Medical University's MIS (Minimally Invasive Surgery) Center, which included the general surgery team with extensive experience in open surgery, laparoscopic surgery, and Da Vinci surgery. The study collected a five-year dataset of patients from July 2015 to September 2019 at Chung Shan Medical University Hospital. A total of 486 patients (mean age = 57.96 ± 15.71 years) were enrolled in this study, comprising 269 males (mean age = 58.39 ± 15.49 years) and 217 female patients (mean age = 57.48 ± 16.00 years). All patients underwent robotic surgery for gastrectomy, liver resection, or pancreatectomy during the study period.
- Regardless of the surgical methods (laparotomy, laparoscopy, or da Vinci system), the first step after the patient enters the operating room is always anesthesia. After administering anesthesia, the following different operation procedures result in different viewing images. During laparotomy, the surgeon opens the patient's body directly and operates with the naked eye. One disadvantage of laparotomy is that large wounds require more time to recover. In 2-dimensional (2D) image laparoscopy, a 2D screen shows an image that allows the surgeon to perform stereoscopic surgery. Although most surgical processes are similar between laparoscopy and robotic surgery, the imaging system has undergone significant improvements in robotic surgery. In surgery using the da Vinci system, an endoscope that captures high-definition 3-dimensional (3D) images from the surgical site is utilized. Images are processed using a video processor in the vision cart and displayed on a 3D viewer and touchscreen.
- Statistical analysis was performed using SPSS version 20.0. One-way ANOVA was used to analyze two or more variables, and statistical significance was set at p < 0.05. In this study, we analyzed the relationship between three different groups of surgical methods and three perioperative outcomes (operative time, hospital stay, and bleeding) in the context of four Hepato-Pancreato-Biliary Surgery (HPB) surgeries.
- Conditions
- Stomach Neoplasms, Pancreatic Neoplasms, Liver Neoplasms, Periampullary Neoplasms, Cholangiocarcinoma, Chronic Pancreatitis
- Keywords
- Whipple, hepatectomy, pancreatectomy, gastrectomy robotic surger, da Vinci Xi
- Medical subject headings
- Stomach Neoplasms, Pancreatic Neoplasms, Liver Neoplasms, Cholangiocarcinoma, Pancreatitis, Chronic, Pancreatic Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| three surgical methods in Laparotomy, Laparoscope, and da Vinci | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative time
The duration of the operation
Measured: From entry into the operating room for anesthesia induction to completion of skin closure at the end of surgery (Day 1, intraoperative period), assessed over an estimated duration of up to 10 hours
bleeding
The amount of intraoperative bleeding
Measured: From initiation of surgery (skin incision) to completion of wound closure during surgery (Day 1, intraoperative period), assessed over an estimated duration of up to 10 hours.
Secondary outcomes (1)
hospital stay
The postoperative recovery time
Measured: From the date of surgery to the date of hospital discharge, assessed up to 55 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Jul 2015
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
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.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 486 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- National Chung Hsing University
- Sponsor type
- University, hospital or other
- Collaborators
- Chung Shan Medical University
- Responsible party
- Principal investigator, LIN, Ming-Hung, National Chung Hsing University
- Investigators
- Cheng-Ming Peng, MD, Ph.D., Study director, Department of Surgery, da Vinci Minimally Invasive Surgery Center, Chung Shan Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034495
- Sponsor's protocol ID
- CS1-20103
- Status last verified
- Jun 2025
- First submitted
- 1 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy concerns and institutional policies that restrict the disclosure of patient-level data, even in de-identified form. Additionally, there is currently no plan or infrastructure in place for secure data sharing in accordance with applicable ethical and legal standards.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing of Laparotomy, Laparoscopy, and daVinci in Whipple, Hepatectomy, Pancreatectomy, and Gastrectomy
- ClinicalTrials.gov ID
- NCT07034495
- Acronym / sponsor ID
- CS1-20103
- Conditions
- Stomach Neoplasms, Pancreatic Neoplasms, Liver Neoplasms, Periampullary Neoplasms, Cholangiocarcinoma, Chronic Pancreatitis
- Keywords
- Whipple, hepatectomy, pancreatectomy, gastrectomy robotic surger, da Vinci Xi
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 486 participants (actual)
- Lead sponsor
- National Chung Hsing UniversityUniversity, hospital or other
- Collaborators
- Chung Shan Medical University
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 24 Jun 2025 (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.
- This study looks at whether newer surgical tools-like the da Vinci robotic system-can help patients recover better after major abdominal surgeries. It compares three surgery methods: traditional open surgery, standard laparoscopic (minimally invasive) surgery, and robotic surgery.
- The research focused on four common operations: Stomach surgery (gastrectomy), Pancreas surgery (pancreatectomy), Liver surgery (hepatectomy) and andWhipple procedure
- Researchers looked at medical records from 486 patients over five years. They compared how long each surgery took, how much blood was lost, and how many days patients stayed in the hospital.
- The study wanted to see if robotic and laparoscopic surgeries help patients by making the surgery faster, safer, and with a quicker recovery.
- The benefits depended on the type of surgery. In many cases, robotic and laparoscopic surgery led to shorter hospital stays, less bleeding, or faster surgeries. These results suggest that using newer technology can help make surgeries safer and recovery easier for patients.
Detailed description
- The study was conducted with the assistance of Chung Shan Medical University's MIS (Minimally Invasive Surgery) Center, which included the general surgery team with extensive experience in open surgery, laparoscopic surgery, and Da Vinci surgery. The study collected a five-year dataset of patients from July 2015 to September 2019 at Chung Shan Medical University Hospital. A total of 486 patients (mean age = 57.96 ± 15.71 years) were enrolled in this study, comprising 269 males (mean age = 58.39 ± 15.49 years) and 217 female patients (mean age = 57.48 ± 16.00 years). All patients underwent robotic surgery for gastrectomy, liver resection, or pancreatectomy during the study period.
- Regardless of the surgical methods (laparotomy, laparoscopy, or da Vinci system), the first step after the patient enters the operating room is always anesthesia. After administering anesthesia, the following different operation procedures result in different viewing images. During laparotomy, the surgeon opens the patient's body directly and operates with the naked eye. One disadvantage of laparotomy is that large wounds require more time to recover. In 2-dimensional (2D) image laparoscopy, a 2D screen shows an image that allows the surgeon to perform stereoscopic surgery. Although most surgical processes are similar between laparoscopy and robotic surgery, the imaging system has undergone significant improvements in robotic surgery. In surgery using the da Vinci system, an endoscope that captures high-definition 3-dimensional (3D) images from the surgical site is utilized. Images are processed using a video processor in the vision cart and displayed on a 3D viewer and touchscreen.
- Statistical analysis was performed using SPSS version 20.0. One-way ANOVA was used to analyze two or more variables, and statistical significance was set at p < 0.05. In this study, we analyzed the relationship between three different groups of surgical methods and three perioperative outcomes (operative time, hospital stay, and bleeding) in the context of four Hepato-Pancreato-Biliary Surgery (HPB) surgeries.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| three surgical methods in Laparotomy, Laparoscope, and da Vinci | – | –no intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A population that needs robotic surgery for gastrectomy, liver resection, or pancreatectomy
Key inclusion criteria (5 listed)
- Adult patients (age ≥ 18 years)
- Underwent one of the following surgeries: gastrectomy, liver resection, or pancreatectomy
- Received surgery at Chung Shan Medical University Hospital between July 2015 and September 2019
- Surgery performed by the general surgery team with experience in open, laparoscopic, and robotic (da Vinci) surgery
- Surgical method included one of the following: open surgery (laparotomy), laparoscopic surgery, or robotic (da Vinci) surgery
Key exclusion criteria (3 listed)
- Patients who underwent surgeries outside the specified types (i.e., not gastrectomy, liver resection, or pancreatectomy)
- Patients with incomplete or missing perioperative data (e.g., operative time, blood loss, or hospital stay)
- Patients who underwent combined or staged surgical procedures unrelated to the HPB domain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
operative time
Time frame: From entry into the operating room for anesthesia induction to completion of skin closure at the end of surgery (Day 1, intraoperative period), assessed over an estimated duration of up to 10 hours
The duration of the operation
bleeding
Time frame: From initiation of surgery (skin incision) to completion of wound closure during surgery (Day 1, intraoperative period), assessed over an estimated duration of up to 10 hours.
The amount of intraoperative bleeding
1 secondary outcome
hospital stay
Time frame: From the date of surgery to the date of hospital discharge, assessed up to 55 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy concerns and institutional policies that restrict the disclosure of patient-level data, even in de-identified form. Additionally, there is currently no plan or infrastructure in place for secure data sharing in accordance with applicable ethical and legal standards.
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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.
Cheng-Ming Peng, MD, Ph.D. study director
Department of Surgery, da Vinci Minimally Invasive Surgery Center, Chung Shan Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stomach Neoplasms and Pancreatic Neoplasms, run by National Chung Hsing University at 1 site in Taiwan.
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 5 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: finished, as of the sponsor's last update on 24 Jun 2025. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
operative time (time frame: From entry into the operating room for anesthesia induction to completion of skin closure at the end of surgery (Day 1, intraoperative period), assessed over an estimated duration of up to 10 hours). 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?
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 24 Jun 2025.