Stomach NeoplasmsMDSGNCT02289183
Prospective Study on Modified Delta-shaped Gastroduodenostomy in Totally Laparoscopic Surgery for Distal Gastric Cancer
A study testing Totally laparoscopic distal gastrectomy and Laparoscopy-assisted distal gastrectomy in people with Stomach Neoplasms, run by Fujian Medical University at 1 site in China.
Trial summary
The purpose of this study is to explore the clinical application value of modified delta-shaped gastroduodenostomy in totally laparoscopic surgery for distal gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- Totally laparoscopic distal gastrectomy and Laparoscopy-assisted distal gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to Dec 2023
- 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
- Age from 18 to 75 years (including 18 and 75 years old)
- Primary distal gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- cT1-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
- Expected curative resection through distal subtotal gastrectomy with D2 lymphadenectomy
- Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
- American Society of Anesthesiology score (ASA) class I, II, or III
- Written informed consent
Who cannot join
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
- Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
- History of other malignant disease within past five years
Show all 13Show fewer
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within past six months
- History of cerebrovascular accident within past six months
- History of continuous systematic administration of corticosteroids within one month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- FEV1<50% of predicted values
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Controlled Trial on Clinical Application Value of Modified Delta-shaped Gastroduodenostomy in Totally Laparoscopic Surgery and Billroth-I Anastomosis in Laparoscopy-assisted Surgery for Distal Gastric Cancer
The purpose of this study is to explore the clinical application value of modified delta-shaped gastroduodenostomy in totally laparoscopic surgery for distal gastric cancer.
Read the detailed description
A prospective randomized comparison of the modified delta-shaped gastroduodenostomy in totally laparoscopic surgery and Billroth-I anastomosis in laparoscopy-assisted surgery for distal gastric cancer will be performed, to evaluate the clinical value and provide theoretical basis and clinical experience for the extensive application of the modified technique. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.
- Conditions
- Stomach Neoplasms
- Being tested
- Totally laparoscopic distal gastrectomy, Laparoscopy-assisted distal gastrectomy
- Keywords
- Stomach Neoplasms, Laparoscopy, Billroth I Operation
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Totally laparoscopic distal gastrectomyProcedure or surgery
Totally laparoscopic distal gastrectomy with modified delta-shaped gastroduodenostomy
Laparoscopy-assisted distal gastrectomyProcedure or surgery
Laparoscopy-assisted distal gastrectomy with Billroth-I anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Totally laparoscopic distal gastrectomy | Experimental | The totally laparoscopic distal gastrectomy with modified delta-shaped gastroduodenostomy will be performed for the treatment of patients with distal gastric cancer assigned to this group. Receives: Procedure: Totally laparoscopic distal gastrectomy |
| Laparoscopy-assisted distal gastrectomy | Active comparator | The laparoscopy-assisted distal gastrectomy with Billroth-I anastomosis will be performed for the treatment of patients with distal gastric cancer assigned to this group. Receives: Procedure: Laparoscopy-assisted distal gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease free survival rate
Measured: 36 months
Secondary outcomes (7)
Morbidity and mortality
The early postoperative complication and mortality are defined as the event observed within 30 days after surgery, while the time frame for late complication is the period from postoperative day 31th to the end of month 36th.
Measured: 30 days;36 months
Intraoperative situation
Operation time, intraoperative blood loss and transfusion volume, conversive rate, intraoperative bleeding and viscera damage, and incision length are used to access the intraoperative situation
Measured: 1 day
Postoperative recovery course
Time to first ambulation, flatus, liquid diet and soft diet, duration of postoperative hospital stay and postoperative pain are used to assess the postoperative recovery course.Visual analog pain score method is used to evaluate the difference of postoperative pain degree.
Measured: 10 days
Postoperative nutritional status and quality of life
The variation of weight, cholesterol and albumin on postoperative 3, 6, 9 and 12 months, and the results of endoscopy on postoperative 3 and 12 months are used to access the postoperative nutritional status and quality of life.
Measured: 12 months
Inflammatory and immune response
The daily highest body temperature before discharge and the values of white blood cell count, hemoglobin, C-reactive protein, prealbumin and relevant immune cytokines including T cell percentage, T-helper lymphocytes (CD4+) percentage, T-suppressor lymphocytes (CD8+) percentage, natural killer (NK) cells percentage from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
Measured: 7 days
3-year overall survival rate
Measured: 36 months
3-year recurrence pattern
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study start1 Jan 2015
- Primary completionDec 2020 (estimated)
- Study completionDec 2023 (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 Fujian Medical 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Ming Huang, Prof., Fujian Medical University
- Investigators
- Changming Huang, M.D.,Ph.D., Study chair, Fujian Medical University Union HospitalChaohui Zheng, M.D., Study director, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289183
- Sponsor's protocol ID
- 2015-01
- Acronym
- MDSG
- Status last verified
- Feb 2020
- First submitted
- 4 Nov 2014
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial on Clinical Application Value of Modified Delta-shaped Gastroduodenostomy in Totally Laparoscopic Surgery and Billroth-I Anastomosis in Laparoscopy-assisted Surgery for Distal Gastric Cancer
- ClinicalTrials.gov ID
- NCT02289183
- Acronym / sponsor ID
- MDSG / 2015-01
- Conditions
- Stomach Neoplasms
- Keywords
- Stomach Neoplasms, Laparoscopy, Billroth I Operation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 13 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 purpose of this study is to explore the clinical application value of modified delta-shaped gastroduodenostomy in totally laparoscopic surgery for distal gastric cancer.
Detailed description
A prospective randomized comparison of the modified delta-shaped gastroduodenostomy in totally laparoscopic surgery and Billroth-I anastomosis in laparoscopy-assisted surgery for distal gastric cancer will be performed, to evaluate the clinical value and provide theoretical basis and clinical experience for the extensive application of the modified technique. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Totally laparoscopic distal gastrectomy | Experimental | Procedure: Totally laparoscopic distal gastrectomyThe totally laparoscopic distal gastrectomy with modified delta-shaped gastroduodenostomy will be performed for the treatment of patients with distal gastric cancer assigned to this group. |
| Laparoscopy-assisted distal gastrectomy | Active comparator | Procedure: Laparoscopy-assisted distal gastrectomyThe laparoscopy-assisted distal gastrectomy with Billroth-I anastomosis will be performed for the treatment of patients with distal gastric cancer assigned to this group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age from 18 to 75 years (including 18 and 75 years old)
- Primary distal gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- cT1-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
- Expected curative resection through distal subtotal gastrectomy with D2 lymphadenectomy
- Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
Key exclusion criteria (13 listed)
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
- Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
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 |
|---|---|---|
| Totally laparoscopic distal gastrectomyTotally laparoscopic distal gastrectomy with modified delta-shaped gastroduodenostomy | Procedure or surgery | Totally laparoscopic distal gastrectomy |
| Laparoscopy-assisted distal gastrectomyLaparoscopy-assisted distal gastrectomy with Billroth-I anastomosis | Procedure or surgery | Laparoscopy-assisted distal gastrectomy |
Primary outcome
3-year disease free survival rate
Time frame: 36 months
7 secondary outcomes
Morbidity and mortality
Time frame: 30 days;36 months
Intraoperative situation
Time frame: 1 day
Postoperative recovery course
Time frame: 10 days
Postoperative nutritional status and quality of life
Time frame: 12 months
Inflammatory and immune response
Time frame: 7 days
3-year overall survival rate
Time frame: 36 months
3-year recurrence pattern
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- 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.
Changming Huang, M.D.,Ph.D. study chair
Fujian Medical University Union Hospital
Chaohui Zheng, M.D. study director
Fujian Medical University Union Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Totally laparoscopic distal gastrectomy and Laparoscopy-assisted distal gastrectomy in people with Stomach Neoplasms, run by Fujian Medical University at 1 site in China.
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 7 inclusion and 13 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 5 Feb 2020. 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 China. 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?
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?
3-year disease free survival rate (time frame: 36 months). 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 5 Feb 2020.