GallstoneNCT05965466
The Incidence of Gallstones After Gastrectomy
A study testing Distal gastrectomy and radical resection and Total gastrectomy and radical resection in people with Gallstone and Gastric Cancer, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 2 sites in China.
Trial summary
To provide preventive and therapeutic strategies for participants with gallstones after gastric cancer by comparing the risk of postoperative gallbladder stone formation with two different resection ranges using the Roux-en-Y reconstruction modality in radical gastric cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gallstone, Gastric Cancer
- What is being tested?
- Distal gastrectomy and radical resection and Total gastrectomy and radical resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 531 participants
- Where
- 2 sitesChina
- Study dates
- 21 Jul 2023to 16 Nov 2024
- 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 with Gastric Cancer underwent Gastrectomy
Who cannot join
- Age less than 18 years or age greater than 75 years;
- Not Roux-en-Y reconstruction;
- R0 excision is not achieved;
- Previous history of upper abdominal surgery, such as cholecystectomy, gastrectomy;
- Preoperative gallbladder diseases, such as gallstones, gallbladder polyps, chronic cholecystitis;
- Preoperative neoadjuvant chemotherapy or radiotherapy;
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- Previous history of malignant tumours;
- Patients with mental or developmental abnormalities or women during pregnancy or breastfeeding;
- Gastric perforation or bleeding leading to emergency surgery;
- Palliative surgical treatment;
- Incomplete case information.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Hepatopancreatobiliary Surgery Institute of Gansu Province
Lanzhou, Gansu, 730000
Wuwei Tumor Hospital
Wuwei, Gansu, 733099
About this study
Official title: Effect of Gastric Cancer Surgical Resection Extent on Postoperative Gallstone Formation: A Retrospected Cohort Study
To provide preventive and therapeutic strategies for participants with gallstones after gastric cancer by comparing the risk of postoperative gallbladder stone formation with two different resection ranges using the Roux-en-Y reconstruction modality in radical gastric cancer surgery.
Read the detailed description
A large number of clinical studies have found that the incidence of gallstones in patients after radical gastric cancer surgery is higher than that in the normal population. However, the pathogenesis has not been clarified, and the prophylactic removal of the gallbladder in patients with gastric cancer remains controversial. A previous study found a statistically significant incidence of gallbladder stones after Billroth I versus Roux-en-Y in distal gastrectomy for gastric cancer. Therefore, the investigators plan to conduct a retrospected cohort study to collect further participants with gastric cancer who underwent total gastrectomy to answer whether different surgical resection ranges during surgery increase the incidence of gallstones this question.
- Conditions
- Gallstone, Gastric Cancer
- Being tested
- Distal gastrectomy and radical resection, Total gastrectomy and radical resection
- Keywords
- Gallstone, Gastric Cancer, Gastrectomy
- 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.
Distal gastrectomy and radical resectionProcedure or surgery
Distal gastrectomy and Roux-en-Y anastomosis
Total gastrectomy and radical resectionProcedure or surgery
Total gastrectomy and Roux-en-Y anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Distal gastrectomy | Experimental | Distal subtotal gastrectomy was performed after exclusion of contraindications to surgery. Gastrointestinal reconstruction was performed by residual gastrojejunal Roux-en-Y anastomosis. Anastomosis was performed ex vivo or in vivo. Receives: Procedure: Distal gastrectomy and radical resection |
| Total gastrectomy | Sham comparator | Total gastrectomy was performed after the exclusion of contraindications to surgery. Gastrointestinal reconstruction was performed by oesophageal jejunum Roux-en-Y anastomosis. Anastomosis was performed ex vivo or in vivo. Receives: Procedure: Total gastrectomy and radical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of gallstone patients
Two groups of patients with gastric cancer had a follow-up for more than one year and the number of patients with gallbladder stones on B-ultrasound or Computed Tomography (CT)
Measured: 5years
Secondary outcomes (2)
Number of patients with postoperative complications
The number of patients with postoperative complications such as abdominal haemorrhage, fistula, nausea, vomiting, abdominal infection and incision infection in 2 groups of gastric cancer patients
Measured: 5years
Number of patients with bile duct stones
Two groups of patients with gastric cancer had a follow-up for more than one year. Clinical signs such as Charcot's triad and ultrasound, Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) show the number of patients with bile duct stones
Measured: 5years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start21 Jul 2023
- 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 (3)Papers the sponsor has linked to this study.
- Other trials for GallstoneStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Distal gastrectomy and Total gastrectomy
- Masking
- None (open label)
- Enrolment
- 531 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., Principal investigator, Hepatopancreatobiliary Surgery Institute of Gansu Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965466
- Sponsor's protocol ID
- GGBS
- Status last verified
- Nov 2024
- First submitted
- 20 Jul 2023
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 27433395Wu CH, Huang KH, Chen MH, Fang WL, Chao Y, Lo SS, Li AF, Wu CW, Shyr YM. Comparison of the Long-term Outcome Between Billroth-I and Roux-en-Y Reconstruction Following Distal Gastrectomy for Gastric Cancer. J Gastrointest Surg. 2021 Aug;25(8):1955-1961. doi: 10.1007/s11605-020-04867-1. Epub 2020 Nov 17.
PubMed 33205309Zhang B, Nie P, Lin Y, Ma Z, Ma G, Wang Y, Ma Y, Zhao J, Zhang J, Yue P, Jiang N, Zhang X, Tian L, Lu L, Yuan J, Meng W. High incidence of gallstones after Roux-en-Y reconstruction gastrectomy in gastric cancer: a multicenter, long-term cohort study. Int J Surg. 2024 Apr 1;110(4):2253-2262. doi: 10.1097/JS9.0000000000001136.
PubMed 38320088
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
- Effect of Gastric Cancer Surgical Resection Extent on Postoperative Gallstone Formation: A Retrospected Cohort Study
- ClinicalTrials.gov ID
- NCT05965466
- Acronym / sponsor ID
- GGBS
- Conditions
- Gallstone, Gastric Cancer
- Keywords
- Gallstone, Gastric Cancer, Gastrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 531 participants (actual)
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu ProvinceUniversity, hospital or other
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 16 Nov 2024 (actual)
- Study completion
- 16 Nov 2024 (actual)
- First posted
- 28 Jul 2023 (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.
To provide preventive and therapeutic strategies for participants with gallstones after gastric cancer by comparing the risk of postoperative gallbladder stone formation with two different resection ranges using the Roux-en-Y reconstruction modality in radical gastric cancer surgery.
Detailed description
A large number of clinical studies have found that the incidence of gallstones in patients after radical gastric cancer surgery is higher than that in the normal population. However, the pathogenesis has not been clarified, and the prophylactic removal of the gallbladder in patients with gastric cancer remains controversial. A previous study found a statistically significant incidence of gallbladder stones after Billroth I versus Roux-en-Y in distal gastrectomy for gastric cancer. Therefore, the investigators plan to conduct a retrospected cohort study to collect further participants with gastric cancer who underwent total gastrectomy to answer whether different surgical resection ranges during surgery increase the incidence of gallstones this question.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Distal gastrectomy and Total gastrectomy
| Arm | Type | Receives |
|---|---|---|
| Distal gastrectomy | Experimental | Procedure: Distal gastrectomy and radical resectionDistal subtotal gastrectomy was performed after exclusion of contraindications to surgery. Gastrointestinal reconstruction was performed by residual gastrojejunal Roux-en-Y anastomosis. Anastomosis was performed ex vivo or in vivo. |
| Total gastrectomy | Sham comparator | Procedure: Total gastrectomy and radical resectionTotal gastrectomy was performed after the exclusion of contraindications to surgery. Gastrointestinal reconstruction was performed by oesophageal jejunum Roux-en-Y anastomosis. Anastomosis was performed ex vivo or in vivo. |
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 with Gastric Cancer underwent Gastrectomy
Key exclusion criteria (11 listed)
- Age less than 18 years or age greater than 75 years;
- Not Roux-en-Y reconstruction;
- R0 excision is not achieved;
- Previous history of upper abdominal surgery, such as cholecystectomy, gastrectomy;
- Preoperative gallbladder diseases, such as gallstones, gallbladder polyps, chronic cholecystitis;
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 |
|---|---|---|
| Distal gastrectomy and radical resectionDistal gastrectomy and Roux-en-Y anastomosis | Procedure or surgery | Distal gastrectomy |
| Total gastrectomy and radical resectionTotal gastrectomy and Roux-en-Y anastomosis | Procedure or surgery | Total gastrectomy |
Primary outcome
Number of gallstone patients
Time frame: 5years
Two groups of patients with gastric cancer had a follow-up for more than one year and the number of patients with gallbladder stones on B-ultrasound or Computed Tomography (CT)
2 secondary outcomes
Number of patients with postoperative complications
Time frame: 5years
Number of patients with bile duct stones
Time frame: 5years
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.
- Results publication: 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.
- Results publication: PubMed 33205309Wu CH, Huang KH, Chen MH, Fang WL, Chao Y, Lo SS, Li AF, Wu CW, Shyr YM. Comparison of the Long-term Outcome Between Billroth-I and Roux-en-Y Reconstruction Following Distal Gastrectomy for Gastric Cancer. J Gastrointest Surg. 2021 Aug;25(8):1955-1961. doi: 10.1007/s11605-020-04867-1. Epub 2020 Nov 17.
- Derived from this study: PubMed 38320088Zhang B, Nie P, Lin Y, Ma Z, Ma G, Wang Y, Ma Y, Zhao J, Zhang J, Yue P, Jiang N, Zhang X, Tian L, Lu L, Yuan J, Meng W. High incidence of gallstones after Roux-en-Y reconstruction gastrectomy in gastric cancer: a multicenter, long-term cohort study. Int J Surg. 2024 Apr 1;110(4):2253-2262. doi: 10.1097/JS9.0000000000001136.
- 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.
Wenbo Meng, M.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?
A study testing Distal gastrectomy and radical resection and Total gastrectomy and radical resection in people with Gallstone 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 1 inclusion and 11 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. Some participants in this study may receive a placebo. 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: 5years). 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 NCT05965466, which also lists 3 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.