Duodenal Stump LeakNCT03085199
Laparoscopic Reinforcement Suture (LARS) of Duodenal Stump A Prospective Single Arm Phase II Study
A study testing Laparoscopic reinforcement suture in people with Duodenal Stump Leak, run by Inje University at 1 site in South Korea.
Trial summary
Until now, no prospective clinical trial for duodenal stump leakage after laparoscopic or open gastrectomy for gastric cancer patients has been conducted. We already introduced a technique of laparoscopic reinforcement suture (LARS) on staple-line of duodenal stump using barbed suture for prevention of duodenal stump… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Duodenal Stump Leak
- What is being tested?
- Laparoscopic reinforcement suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2016to Dec 2017
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically proven gastric adenocarcinoma that were treated with laparoscopic distal or total gastrectomy and B-II or Roux en Y reconstruction and age of above 19 years
Who cannot join
- history of previous abdominal surgery except cholecystectomy and would be performed combined abdominal surgery except cholecystectomy. And also patients with advanced gastric cancer with gastric outlet obstruction or cancer invasion to pylorus
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
University of Inje College of Medicine, Haeundae Paik Hopsital
Busan, 612-030
min seop Song, 82-51-797-2747, hpirb@paik.ac.kr
kwan woo kim
About this study
Official title: Laparoscopic Reinforcement Suture (LARS) on Staple-line of Duodenal Stump Using Barbed Suture in Laparoscopic Gastrectomy for Gastric Cancer: A Prospective Single Arm Phase II Study
Until now, no prospective clinical trial for duodenal stump leakage after laparoscopic or open gastrectomy for gastric cancer patients has been conducted.
We already introduced a technique of laparoscopic reinforcement suture (LARS) on staple-line of duodenal stump using barbed suture for prevention of duodenal stump leakage. Therefore, a prospective phase II study was designed for safety of this technique.
Read the detailed description
As the results of recent prospective randomized controlled clinical trials, laparoscopic gastrectomy has been accepted by one of standard treatments for early gastric cancer in Korea, Japan and China.
However, duodenal stump leakage remains one of the fetal complications after gastrectomy until now. The incidence of duodenal stump leakage is reportedly between 1.6% to 5% in Billroth II or Roux en Y reconstruction after gastrectomy for gastric cancer. According to a recent multicenter study, the laparoscopic approach increased the risk of duodenal stump leakage development comparing to open approach.
Until now, no prospective clinical trial for duodenal stump leakage after laparoscopic or open gastrectomy for gastric cancer patients has been conducted. I already introduced a technique of laparoscopic reinforcement suture (LARS) on staple-line of duodenal stump using barbed suture for prevention of duodenal stump leakage. Therefore, a prospective phase II study was designed for safety of this technique.
- Conditions
- Duodenal Stump Leak
- Being tested
- Laparoscopic reinforcement suture
- Keywords
- gastric cancer, laparoscopic gastrectomy, laparoscopic reinforcement suture (LARS)
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic reinforcement sutureProcedure or surgery
After cutting of duodenal stump of about 2 cm length using linear stapler, LARS commenced from upper to lower part on staple-line of duodenal stump. Continuous suture with invagination was performed using a barbed suture. In case of patient with short duodenal stump because of chronic ulcer or ectopic pancreas at duodenal bulb, 2 or 3 interrupted sutures without invagination of duodenal stump was conducted using barbed sutures.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic reinforcement suture | Other | After cutting of duodenal stump of about 2 cm length using linear stapler, laparoscopic reinforcement suture commenced from upper to lower part on staple-line of duodenal stump. Continuous suture with invagination was performed using a barbed suture. In case of patient with short duodenal stump because of chronic ulcer or ectopic pancreas at duodenal bulb, 2 or 3 interrupted sutures without invagination of duodenal stump was conducted using barbed sutures. Receives: Procedure: Laparoscopic reinforcement suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of duodenal stump fistula within postoperative 30 days
Duodenal stump fistula was defined as clinical suspicion, laboratory finding of fluid from drain or radiologic finding such as CT scan or fistulogram.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study startMar 2016
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Duodenal Stump LeakStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kwan Woo Kim, Dong-A University Hospital
- Investigators
- kwan woo kim, phd, Principal investigator, Dong-A University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085199
- Sponsor's protocol ID
- DAUHIRB-16-010
- Status last verified
- Mar 2017
- First submitted
- 15 Mar 2017
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ali BI, Park CH, Song KY. Outcomes of Non-Operative Treatment for Duodenal Stump Leakage after Gastrectomy in Patients with Gastric Cancer. J Gastric Cancer. 2016 Mar;16(1):28-33. doi: 10.5230/jgc.2016.16.1.28. Epub 2016 Mar 31.
PubMed 27104024
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Reinforcement Suture (LARS) on Staple-line of Duodenal Stump Using Barbed Suture in Laparoscopic Gastrectomy for Gastric Cancer: A Prospective Single Arm Phase II Study
- ClinicalTrials.gov ID
- NCT03085199
- Acronym / sponsor ID
- DAUHIRB-16-010
- Conditions
- Duodenal Stump Leak
- Keywords
- gastric cancer, laparoscopic gastrectomy, laparoscopic reinforcement suture (LARS)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 21 Mar 2017 (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.
Until now, no prospective clinical trial for duodenal stump leakage after laparoscopic or open gastrectomy for gastric cancer patients has been conducted.
We already introduced a technique of laparoscopic reinforcement suture (LARS) on staple-line of duodenal stump using barbed suture for prevention of duodenal stump leakage. Therefore, a prospective phase II study was designed for safety of this technique.
Detailed description
As the results of recent prospective randomized controlled clinical trials, laparoscopic gastrectomy has been accepted by one of standard treatments for early gastric cancer in Korea, Japan and China.
However, duodenal stump leakage remains one of the fetal complications after gastrectomy until now. The incidence of duodenal stump leakage is reportedly between 1.6% to 5% in Billroth II or Roux en Y reconstruction after gastrectomy for gastric cancer. According to a recent multicenter study, the laparoscopic approach increased the risk of duodenal stump leakage development comparing to open approach.
Until now, no prospective clinical trial for duodenal stump leakage after laparoscopic or open gastrectomy for gastric cancer patients has been conducted. I already introduced a technique of laparoscopic reinforcement suture (LARS) on staple-line of duodenal stump using barbed suture for prevention of duodenal stump leakage. Therefore, a prospective phase II study was designed for safety of this technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic reinforcement suture | Other | Procedure: Laparoscopic reinforcement sutureAfter cutting of duodenal stump of about 2 cm length using linear stapler, laparoscopic reinforcement suture commenced from upper to lower part on staple-line of duodenal stump. Continuous suture with invagination was performed using a barbed suture. In case of patient with short duodenal stump because of chronic ulcer or ectopic pancreas at duodenal bulb, 2 or 3 interrupted sutures without invagination of duodenal stump was conducted using barbed sutures. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- histologically proven gastric adenocarcinoma that were treated with laparoscopic distal or total gastrectomy and B-II or Roux en Y reconstruction and age of above 19 years
Key exclusion criteria (1 listed)
- history of previous abdominal surgery except cholecystectomy and would be performed combined abdominal surgery except cholecystectomy. And also patients with advanced gastric cancer with gastric outlet obstruction or cancer invasion to pylorus
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 |
|---|---|---|
| Laparoscopic reinforcement sutureAfter cutting of duodenal stump of about 2 cm length using linear stapler, LARS commenced from upper to lower part on staple-line of duodenal stump. Continuous suture with invagination was performed using a barbed suture. In case of patient with short duodenal stump because of chronic ulcer or ectopic pancreas at duodenal bulb, 2 or 3 interrupted sutures without invagination of duodenal stump was conducted using barbed sutures. | Procedure or surgery | Laparoscopic reinforcement suture |
Primary outcome
the incidence of duodenal stump fistula within postoperative 30 days
Time frame: 30 days
Duodenal stump fistula was defined as clinical suspicion, laboratory finding of fluid from drain or radiologic finding such as CT scan or fistulogram.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
- Results publication: PubMed 27104024Ali BI, Park CH, Song KY. Outcomes of Non-Operative Treatment for Duodenal Stump Leakage after Gastrectomy in Patients with Gastric Cancer. J Gastric Cancer. 2016 Mar;16(1):28-33. doi: 10.5230/jgc.2016.16.1.28. Epub 2016 Mar 31.
- Individual participant dataSharing planned: No
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.
kwan woo kim, phd principal investigator
Dong-A University 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 Laparoscopic reinforcement suture in people with Duodenal Stump Leak, run by Inje University 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 1 inclusion and 1 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 21 Mar 2017. 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.
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?
Contact kwan woo kim, phd (82-51-240-2905, d002045@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of duodenal stump fistula within postoperative 30 days (time frame: 30 days). 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 NCT03085199, which also lists 1 linked publication.
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 21 Mar 2017.