GallstonesNCT04250402
The Incidence of Gallstones After Gastric Cancer Surgery
An observational study of Gallstones and Gastric Cancer, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 2 sites in China.
Trial summary
Through previous clinical observations and literature, we found that the incidence of gallstones in patients after gastric cancer radical resection was significantly higher than that in the normal population (4%). However, its pathogenesis has not been clarified. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gallstones, Gastric Cancer
- What is being tested?
- Resection
- Type of treatment
- Surgery or procedure
- How many people
- 1,019 participants
- Where
- 2 sitesChina
- Study dates
- 14 Feb 2020to 16 Nov 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Gastric cancer patients
Who may be able to join
- Gastric cancer patients
- Age from over 18 to under 75 years
Who cannot join
- Gallbladder disease before surgery
- Gallbladder has been remove
- History of previous upper abdominal surgery
- History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
- History of other malignant disease within past five years
- History of previous neoadjuvant chemotherapy or radiotherapy
Show all 15Show fewer
- History of unstable angina or myocardial infarction within past six months
- History of cerebrovascular accident within past six months
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- Pregnant women or breastfeeding
- Unwillingness or inability to consent for the study
- Severe mental disorder
- Unstable vital signs Coagulation dysfunction (INR>1.5)
- Low peripheral blood platelet count (<50×10 ^9 / L) or using anti- coagulation drugs
Trial locations and contacts
2 sites in 1 country.
China2 sites
Hepatopancreatobiliary Surgery Institute of Gansu Province
Lanzhou, Gansu, 730000
Wuwei turmour hospital
Wuwei, Gansu, 733000
About this study
Official title: The Incidence Risks of Gallstones After Radical Surgery in Different Types of Gastric Cancer
Through previous clinical observations and literature, we found that the incidence of gallstones in patients after gastric cancer radical resection was significantly higher than that in the normal population (4%). However, its pathogenesis has not been clarified. We compare the risk of gallbladder stones after four different radical gastric cancer surgical methods, in order to provide prevention and treatment strategies for people with gallstones after gastric cancer.
Read the detailed description
A large number of clinical studies have found that the incidence of gallstones in patients with radical gastric cancer is higher than that in the normal population. However, its pathogenesis has not been clarified, and there is still controversy about the prophylactic removal of gallbladder in patients with gastric cancer. The investigator's previous study found that there was no statistical difference in the incidence of gallstones after laparoscopic distal gastrectomy (LDG), laparoscopic total gastrectomy (LTG) and laparoscopic proximal gastrectomy (LPG). A common feature of the three surgical methods is that the vagus nerve were more or less cut during the operation. Therefore, we plan to further collect gastric cancer patients undergoing endoscopic submucosal dissection (ESD) surgery in order to answer whether the vagus nerve cut during surgery will increase the incidence of gallstones.
- Conditions
- Gallstones, Gastric Cancer
- Being tested
- Resection
- Keywords
- Gallstones, Gastric cancer, Gastrectomy, ESD, Vagus nerve
- Medical subject headings
- Gallstones, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResectionProcedure or surgery
Radical resection.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Endoscopic submucosal dissection. Endoscopic submucosal dissection is an endoscopic procedure which can achieve en bloc resection of GI tumor. ESD is characterized by three steps: injecting fluid into the submucosa to elevate the lesion from the muscle layer, circumferential cutting of the surrounding mucosa of the lesion, and subsequent dissection of the connective tissue of the submucosa beneath the lesion. The ESD procedure will be carried out by experienced endoscopists.
Other Name: ESD Receives: Procedure: Resection | |
| Arm 2 | Distal subtotal gastrectomy with D2 lymphadenectomy. After exclusion of T4b, bulky lymph nodes, or distant metastasis case, distal subtotal gastrectomy and D2 lymph node dissection will be performed with curative treated intent.
The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally. Receives: Procedure: Resection | |
| Arm 3 | Total gastrectomy with D2 lymphadenectomy will be performed with curative treated intent. The type of reconstruction will be with jejunal interposition reconstruction. Receives: Procedure: Resection | |
| Arm 4 | Proximal gastrectomy with D2 lymphadenectomy. The type of reconstruction will be jejunal interposition with double anastomosis method. Receives: Procedure: Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of gallstone patients
Four different gastric cancer patients were followed up for more than 1 year. The number of patients with gallbladder stones revealed by B-ultrasound
Measured: 3 years
Secondary outcomes (3)
Number of malignant metastasis
Number of malignant metastases after radical gastrectomy in surgery methods of gastric cancer patients
Measured: 3 years
Number of short-term deaths
Number of short-term deaths after radical gastrectomy in surgery methods of gastric cancer patients
Measured: 3 months
Number of physical regurgitation, nausea, vomiting, diarrhea, constipation
The number of physical regurgitation, nausea, vomiting, diarrhea, constipation, and other events that affect quality of life in four surgery methods of gastric cancer patients
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start14 Feb 2020
- Primary completion16 Nov 2024
- Study completion16 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GallstonesStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,019 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenbo Meng, Hepatopancreatobiliary Surgery Institute of Gansu Province
- Investigators
- Wenbo Meng, M.D., Ph. D., Principal investigator, Hepatopancreatobiliary Surgery Institute of Gansu Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250402
- Sponsor's protocol ID
- Gallstones after gastrectomy
- Status last verified
- Nov 2024
- First submitted
- 29 Jan 2020
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Park DJ, Kim KH, Park YS, Ahn SH, Park do J, Kim HH. Risk Factors for Gallstone Formation after Surgery for Gastric Cancer. J Gastric Cancer. 2016 Jun;16(2):98-104. doi: 10.5230/jgc.2016.16.2.98. Epub 2016 Jun 24.
PubMed 27433395Furukawa H, Ohashi M, Honda M, Kumagai K, Nunobe S, Sano T, Hiki N. Preservation of the celiac branch of the vagal nerve for pylorus-preserving gastrectomy: is it meaningful? Gastric Cancer. 2018 May;21(3):516-523. doi: 10.1007/s10120-017-0776-8. Epub 2017 Nov 10.
PubMed 29127549
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence Risks of Gallstones After Radical Surgery in Different Types of Gastric Cancer
- ClinicalTrials.gov ID
- NCT04250402
- Acronym / sponsor ID
- Gallstones after gastrectomy
- Conditions
- Gallstones, Gastric Cancer
- Keywords
- Gallstones, Gastric cancer, Gastrectomy, ESD, Vagus nerve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,019 participants (actual)
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu ProvinceUniversity, hospital or other
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 16 Nov 2024 (actual)
- Study completion
- 16 Nov 2024 (actual)
- First posted
- 31 Jan 2020 (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.
Through previous clinical observations and literature, we found that the incidence of gallstones in patients after gastric cancer radical resection was significantly higher than that in the normal population (4%). However, its pathogenesis has not been clarified. We compare the risk of gallbladder stones after four different radical gastric cancer surgical methods, in order to provide prevention and treatment strategies for people with gallstones after gastric cancer.
Detailed description
A large number of clinical studies have found that the incidence of gallstones in patients with radical gastric cancer is higher than that in the normal population. However, its pathogenesis has not been clarified, and there is still controversy about the prophylactic removal of gallbladder in patients with gastric cancer. The investigator's previous study found that there was no statistical difference in the incidence of gallstones after laparoscopic distal gastrectomy (LDG), laparoscopic total gastrectomy (LTG) and laparoscopic proximal gastrectomy (LPG). A common feature of the three surgical methods is that the vagus nerve were more or less cut during the operation. Therefore, we plan to further collect gastric cancer patients undergoing endoscopic submucosal dissection (ESD) surgery in order to answer whether the vagus nerve cut during surgery will increase the incidence of gallstones.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Procedure: ResectionEndoscopic submucosal dissection. Endoscopic submucosal dissection is an endoscopic procedure which can achieve en bloc resection of GI tumor. ESD is characterized by three steps: injecting fluid into the submucosa to elevate the lesion from the muscle layer, circumferential cutting of the surrounding mucosa of the lesion, and subsequent dissection of the connective tissue of the submucosa beneath the lesion. The ESD procedure will be carried out by experienced endoscopists. Other Name: ESD |
| Arm 2 | – | Procedure: ResectionDistal subtotal gastrectomy with D2 lymphadenectomy. After exclusion of T4b, bulky lymph nodes, or distant metastasis case, distal subtotal gastrectomy and D2 lymph node dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally. |
| Arm 3 | – | Procedure: ResectionTotal gastrectomy with D2 lymphadenectomy will be performed with curative treated intent. The type of reconstruction will be with jejunal interposition reconstruction. |
| Arm 4 | – | Procedure: ResectionProximal gastrectomy with D2 lymphadenectomy. The type of reconstruction will be jejunal interposition with double anastomosis method. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Gastric cancer patients
Key inclusion criteria (2 listed)
- Gastric cancer patients
- Age from over 18 to under 75 years
Key exclusion criteria (15 listed)
- Gallbladder disease before surgery
- Gallbladder has been remove
- History of previous upper abdominal surgery
- History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
- History of other malignant disease within past five years
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 |
|---|---|---|
| ResectionRadical resection. | Procedure or surgery | Arm 1, Arm 2, Arm 3, Arm 4 |
Primary outcome
Number of gallstone patients
Time frame: 3 years
Four different gastric cancer patients were followed up for more than 1 year. The number of patients with gallbladder stones revealed by B-ultrasound
3 secondary outcomes
Number of malignant metastasis
Time frame: 3 years
Number of short-term deaths
Time frame: 3 months
Number of physical regurgitation, nausea, vomiting, diarrhea, constipation
Time frame: 3 years
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 19 Nov 2024.
- Background: PubMed 27433395Park DJ, Kim KH, Park YS, Ahn SH, Park do J, Kim HH. Risk Factors for Gallstone Formation after Surgery for Gastric Cancer. J Gastric Cancer. 2016 Jun;16(2):98-104. doi: 10.5230/jgc.2016.16.2.98. Epub 2016 Jun 24.
- Background: PubMed 29127549Furukawa H, Ohashi M, Honda M, Kumagai K, Nunobe S, Sano T, Hiki N. Preservation of the celiac branch of the vagal nerve for pylorus-preserving gastrectomy: is it meaningful? Gastric Cancer. 2018 May;21(3):516-523. doi: 10.1007/s10120-017-0776-8. Epub 2017 Nov 10.
- Individual participant dataSharing planned: Undecided
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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.
Wenbo Meng, M.D., Ph. D. principal investigator
Hepatopancreatobiliary Surgery Institute of Gansu Province
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gallstones and Gastric Cancer, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 2 sites 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 2 inclusion and 15 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 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Number of gallstone patients (time frame: 3 years). 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 NCT04250402, which also lists 2 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 19 Nov 2024.