Stomach NeoplasmsPhase 2NCT04539769
Impact of the Type of Reconstruction Methods on Diabetes Following Laparoscopic Distal Gastrectomy in Patients With Gastric Cancer and Type 2 Diabetes
A Phase 2 study testing conventional BI, long-limb BII and long-limb RY group in people with Stomach Neoplasms and Diabetes Mellitus, Type 2, run by Kyungpook National University Chilgok Hospital at 1 site in South Korea.
Trial summary
There is a rapidly growing interest in metabolic surgery for the treatment of type 2 diabetes. However, its efficacy in the non-morbidly population is not clear yet and the underlying mechanism remains elusive. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stomach Neoplasms, Diabetes Mellitus, Type 2
- What is being tested?
- conventional BI, long-limb BII and long-limb RY group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2017to 31 Dec 2019
- Phase
- Phase 2
- 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 diagnosed with type 2 diabetes as well as pathologically proven gastric cancer of clinical stage I according to the AJCC 7th edition
- Those who are expected to undergo laparoscopic distal gastrectomy
- Body mass index < 30 kg/m2
Who cannot join
- baseline fasting C-peptide level < 1.0 ng/dL (who had the possibility of type 1 diabetes)
- previous radiotherapy or surgery at upper abdomen other than laparoscopic cholecystectomy
- other malignancies in recent 5 years
- vulnerable patients (pregnant women, those with cognitive impairment, etc)
- ECOG-PS ≥ 2
- participating in other clinical trials within 6 months
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Kyungpook National University Chilgok Hospital
Daegu, 41404
About this study
There is a rapidly growing interest in metabolic surgery for the treatment of type 2 diabetes. However, its efficacy in the non-morbidly population is not clear yet and the underlying mechanism remains elusive.
Meanwhile, the incidence of early gastric cancer (EGC) in Korea has gradually increased, the long-term quality of life of the patients with EGC has become an important issue. Since the reconstruction methods after gastric cancer surgery are similar to that of metabolic surgery, some surgeons have attempted to modify the reconstruction methods after standard radical gastrectomy to achieve better glycemic control in gastric cancer patients with type 2 diabetes.
Read more
The present study aimed to investigate the changes in glucose metabolism and incretin hormone responses following different types of reconstruction after distal gastrectomy in non-morbidly obese gastric cancer patients with type 2 diabetes. This is a non-randomized, prospective, single-center, phase II pilot study.
Patients diagnosed with stage I gastric cancer and type 2 diabetes are eligible for the present study. Patients who will undergo laparoscopic distal gastrectomy for cancer located at the lower two-thirds of the stomach will only be included. The reconstruction method will be selected among conventional Billroth I, long-limb Billroth II (with 100 cm-long biliopancreatic limb), or long-limb Roux-en-Y (with 100 cm-long Roux limb) reconstruction methods according to the surgeon's preference as well as the size of the remnant stomach. All the patients are subjected to a 75g-oral glucose tolerance test (OGTT) preoperatively, and at 5 days, 3 months, 6 months postoperatively and serum glucose, as well as incretin hormones, will be serially measured.
- Conditions
- Stomach Neoplasms, Diabetes Mellitus, Type 2
- Being tested
- conventional BI, long-limb BII, long-limb RY group
- Medical subject headings
- Stomach Neoplasms, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional BIProcedure or surgery
After standard laparoscopic distal gastrectomy with radical lymphadenectomy, the gastrointestinal continuity will be restored with conventional Billroth I gastroduodenostomy.
long-limb BIIProcedure or surgery
After standard laparoscopic distal gastrectomy with radical lymphadenectomy, the gastrointestinal continuity will be restored with Billroth II gastrojejunostomy using 100 cm-long biliopancreatic limb.
long-limb RY groupProcedure or surgery
After standard laparoscopic distal gastrectomy with radical lymphadenectomy, the gastrointestinal continuity will be restored with Roux-en-Y reconstruction using 100 cm-long Roux limb and standard biliopancreatic limb.
| Study group | Role | What they receive |
|---|---|---|
| BI group | Active comparator | Conventional Billroth I reconstruction Receives: Procedure: conventional BI |
| BII group | Experimental | Billroth II reconstruction with 100-cm long biliopancreatic limb Receives: Procedure: long-limb BII |
| RY group | Experimental | Roux-en-Y reconstruction with 100-cm long Roux limb Receives: Procedure: long-limb RY group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes remission rate
the rate of patients achieving HbA1c < 6.5% without antidiabetic medications
Measured: at 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start1 Sep 2017
- Primary completion30 Apr 2019
- Study completion31 Dec 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Chilgok Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kyungpook National University Hospital
- Responsible party
- Principal investigator, Ji Yeon Park, Kyungpook National University Chilgok Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539769
- Sponsor's protocol ID
- KNUCH 2017-07-011
- Status last verified
- Aug 2020
- First submitted
- 31 Aug 2020
- Last updated
- 7 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Type of Reconstruction Methods on Diabetes Following Laparoscopic Distal Gastrectomy in Patients With Gastric Cancer and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04539769
- Acronym / sponsor ID
- KNUCH 2017-07-011
- Conditions
- Stomach Neoplasms, Diabetes Mellitus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kyungpook National University Chilgok HospitalUniversity, hospital or other
- Collaborators
- Kyungpook National University Hospital
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 7 Sep 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.
There is a rapidly growing interest in metabolic surgery for the treatment of type 2 diabetes. However, its efficacy in the non-morbidly population is not clear yet and the underlying mechanism remains elusive.
Meanwhile, the incidence of early gastric cancer (EGC) in Korea has gradually increased, the long-term quality of life of the patients with EGC has become an important issue. Since the reconstruction methods after gastric cancer surgery are similar to that of metabolic surgery, some surgeons have attempted to modify the reconstruction methods after standard radical gastrectomy to achieve better glycemic control in gastric cancer patients with type 2 diabetes.
The present study aimed to investigate the changes in glucose metabolism and incretin hormone responses following different types of reconstruction after distal gastrectomy in non-morbidly obese gastric cancer patients with type 2 diabetes. This is a non-randomized, prospective, single-center, phase II pilot study.
Patients diagnosed with stage I gastric cancer and type 2 diabetes are eligible for the present study. Patients who will undergo laparoscopic distal gastrectomy for cancer located at the lower two-thirds of the stomach will only be included. The reconstruction method will be selected among conventional Billroth I, long-limb Billroth II (with 100 cm-long biliopancreatic limb), or long-limb Roux-en-Y (with 100 cm-long Roux limb) reconstruction methods according to the surgeon's preference as well as the size of the remnant stomach. All the patients are subjected to a 75g-oral glucose tolerance test (OGTT) preoperatively, and at 5 days, 3 months, 6 months postoperatively and serum glucose, as well as incretin hormones, will be serially measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BI group | Active comparator | Procedure: conventional BIConventional Billroth I reconstruction |
| BII group | Experimental | Procedure: long-limb BIIBillroth II reconstruction with 100-cm long biliopancreatic limb |
| RY group | Experimental | Procedure: long-limb RY groupRoux-en-Y reconstruction with 100-cm long Roux limb |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with type 2 diabetes as well as pathologically proven gastric cancer of clinical stage I according to the AJCC 7th edition
- Those who are expected to undergo laparoscopic distal gastrectomy
- Body mass index < 30 kg/m2
Key exclusion criteria (6 listed)
- baseline fasting C-peptide level < 1.0 ng/dL (who had the possibility of type 1 diabetes)
- previous radiotherapy or surgery at upper abdomen other than laparoscopic cholecystectomy
- other malignancies in recent 5 years
- vulnerable patients (pregnant women, those with cognitive impairment, etc)
- ECOG-PS ≥ 2
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 |
|---|---|---|
| conventional BIAfter standard laparoscopic distal gastrectomy with radical lymphadenectomy, the gastrointestinal continuity will be restored with conventional Billroth I gastroduodenostomy. | Procedure or surgery | BI group |
| long-limb BIIAfter standard laparoscopic distal gastrectomy with radical lymphadenectomy, the gastrointestinal continuity will be restored with Billroth II gastrojejunostomy using 100 cm-long biliopancreatic limb. | Procedure or surgery | BII group |
| long-limb RY groupAfter standard laparoscopic distal gastrectomy with radical lymphadenectomy, the gastrointestinal continuity will be restored with Roux-en-Y reconstruction using 100 cm-long Roux limb and standard biliopancreatic limb. | Procedure or surgery | RY group |
Primary outcome
Diabetes remission rate
Time frame: at 6 months after surgery
the rate of patients achieving HbA1c < 6.5% without antidiabetic medications
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 7 Sep 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing conventional BI, long-limb BII and long-limb RY group in people with Stomach Neoplasms and Diabetes Mellitus, Type 2, run by Kyungpook National University Chilgok Hospital at 1 site in South Korea.
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 3 inclusion and 6 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 7 Sep 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 South Korea. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Diabetes remission rate (time frame: at 6 months after surgery). 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 7 Sep 2020.