Periampullar DiseaseNCT05088564
Efficacy of Hemi-double-stapling Technique
A study testing Hand-sewn and Hemi-double stapling in people with Periampullar Disease, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
Surgical stapler is used in all areas of surgical operation. Surgical stapler has been used in various surgical fields for a long time, so its stability has already been proven. After gastrectomy or colectomy, the hemi-double stapling technique, which is an improved double stapling technique, has been applied as an… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Periampullar Disease
- What is being tested?
- Hand-sewn and Hemi-double stapling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Apr 2021to 22 Apr 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pylorus-preserving pancreaticoduodenectomy
- ECOG scale 0-1
- Age > 19
- Appropriate organ function as below i.WBC : ≥2500 mm3, ≤14000 mm3 ii.Hemoglobin : ≥9.0 g/dL iii.Platelet : ≥100,000 mm3 iv.Total bilirubin : ≤2.0 mg/dL (except for occlusive jaundice) v.Creatinine : ≤2.0 mg/dL
- patient who can understand and sign the informed consent
Who cannot join
- previous history of gastrectomy
- ulcerative scar around ampulla of duodenum on endoscopy
- previous history of upper abdomen surgery (open)
- Emergency
- Severe ischemic heart disease
- Severe hepatic failure by liver cirrhosis or hepatitis
Show all 13Show fewer
- Severe respiratory failure that requires oxygene inhalation
- Chronic renal failure that requires hemodialysis
- Expecting combine resection of other organ
- Immunosuppressive therapy
- Accompanying cancer with potential for adverse events
- Severe psychologic or neurologic disease
- drug or alcohol addiction
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gangnam Severance Hospital
Seoul
JoonSeoung Park, 82-2-2019-2999, JSPARK330@yuhs.ac
About this study
Official title: Pylorus-preserving Pancreaticoduodenectomy Using a Hemi-double-stapling Technique
Surgical stapler is used in all areas of surgical operation. Surgical stapler has been used in various surgical fields for a long time, so its stability has already been proven. After gastrectomy or colectomy, the hemi-double stapling technique, which is an improved double stapling technique, has been applied as an anastomosis method using a stapler.
In the duodenojejunal anastomosis after PPPD, the hemi-double stapling method can be applied to preserve the pyloric branch of the vagus nerve and the branch of the right gastric artery to ensure sufficient blood supply. Ultimately, it is expected to shorten the anastomosis time as well as reduce the frequency of delayed gastric emptying. In addition, the work of physically expanding the pylorus to insert the circular anastomosis is also thought to reduce gastric emptying delay.
Read the detailed description
(1) Stapling technique
- Make purse-string suture on jejunum at the point of duodenojejunostomy
- Insert Anvil into jejunem
- Make incision of 3-4 centimeters at anterior side of antrum
- Long Kelly forceps are inserted into the stomach to dilate the pylorus
- A 25 mm end-to-end anastomosis (EEA) stapler is inserted into the stomach and passed through the pylorus.
- The needle of EEA stapler is pierced through the lower part of the stapler line where the duodenum has been resected
- The EEA stapler is combined with the anvil and anastomosis is performed
- The incision on the stomach is sutured through a linear stapler
- Reinforcement suture for stapler line (2) Postoperative management
- Diet build up as same manner of hand-sewn group (3) Postoperative follow-up
- All postoperative complication, delayed gastric emptying, intraperitoneal abscess, postoperative pancreatic fistula, postpancreatectomy hemorrhage, hospital stay, reoperation, readmission and 2-months mortality.
- Conditions
- Periampullar Disease
- Being tested
- Hand-sewn, Hemi-double stapling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand-sewnProcedure or surgery
Doudenojejunal anastomosis by hand-sewn method
Hemi-double staplingProcedure or surgery
Doudenojejunal anastomosis by hemi-double-stapling method "EEA25 - Covidien EEA Circular Stapler DST Series 25.0mm x 4.8mm" is used for anastomosis
| Study group | Role | What they receive |
|---|---|---|
| I (Hand-sewn group) | Experimental | Doudenojejunal anastomosis by hand-swen method Receives: Procedure: Hand-sewn |
| II (Stapling group) | Active comparator | Doudenojejunal anastomosis by hemi-double-stapling method Receives: Procedure: Hemi-double stapling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade of delayed gastric emptying by ISGPS
Delayed gastric emptying will be evaluated at postoperative 21 day using International study group of pancreatic surgery (ISGPS) classification. According to ISGPS classification, delayed gastric emptying is divided into three grades from A to C. Grade C means worse than grade A.-->Unit of Measure: Grade A,B,C
Measured: At postoperative 21 day
Secondary outcomes (1)
hospital stay
Duration (days) of hospital stay, which means interval between operation day and discharge day will be checked up to postoperative 2 months. --> Unit of Measure: days
Measured: At postoperative 21 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start23 Apr 2021
- Primary completion22 Apr 2024 (estimated)
- Study completion22 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periampullar DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joon Seong Park, Gangnam Severance Hospital
- Investigators
- Joon Seoung Park, Principal investigator, GangnamSeverance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088564
- Sponsor's protocol ID
- 3-2021-0084
- Status last verified
- Oct 2022
- First submitted
- 8 Aug 2021
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pylorus-preserving Pancreaticoduodenectomy Using a Hemi-double-stapling Technique
- ClinicalTrials.gov ID
- NCT05088564
- Acronym / sponsor ID
- 3-2021-0084
- Conditions
- Periampullar Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- 22 Apr 2024 (estimated)
- Study completion
- 22 Apr 2024 (estimated)
- First posted
- 22 Oct 2021 (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.
Surgical stapler is used in all areas of surgical operation. Surgical stapler has been used in various surgical fields for a long time, so its stability has already been proven. After gastrectomy or colectomy, the hemi-double stapling technique, which is an improved double stapling technique, has been applied as an anastomosis method using a stapler.
In the duodenojejunal anastomosis after PPPD, the hemi-double stapling method can be applied to preserve the pyloric branch of the vagus nerve and the branch of the right gastric artery to ensure sufficient blood supply. Ultimately, it is expected to shorten the anastomosis time as well as reduce the frequency of delayed gastric emptying. In addition, the work of physically expanding the pylorus to insert the circular anastomosis is also thought to reduce gastric emptying delay.
Detailed description
(1) Stapling technique
- Make purse-string suture on jejunum at the point of duodenojejunostomy
- Insert Anvil into jejunem
- Make incision of 3-4 centimeters at anterior side of antrum
- Long Kelly forceps are inserted into the stomach to dilate the pylorus
- A 25 mm end-to-end anastomosis (EEA) stapler is inserted into the stomach and passed through the pylorus.
- The needle of EEA stapler is pierced through the lower part of the stapler line where the duodenum has been resected
- The EEA stapler is combined with the anvil and anastomosis is performed
- The incision on the stomach is sutured through a linear stapler
- Reinforcement suture for stapler line (2) Postoperative management
- Diet build up as same manner of hand-sewn group (3) Postoperative follow-up
- All postoperative complication, delayed gastric emptying, intraperitoneal abscess, postoperative pancreatic fistula, postpancreatectomy hemorrhage, hospital stay, reoperation, readmission and 2-months mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I (Hand-sewn group) | Experimental | Procedure: Hand-sewnDoudenojejunal anastomosis by hand-swen method |
| II (Stapling group) | Active comparator | Procedure: Hemi-double staplingDoudenojejunal anastomosis by hemi-double-stapling method |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- pylorus-preserving pancreaticoduodenectomy
- ECOG scale 0-1
- Age > 19
- Appropriate organ function as below i.WBC : ≥2500 mm3, ≤14000 mm3 ii.Hemoglobin : ≥9.0 g/dL iii.Platelet : ≥100,000 mm3 iv.Total bilirubin : ≤2.0 mg/dL (except for occlusive jaundice) v.Creatinine : ≤2.0 mg/dL
- patient who can understand and sign the informed consent
Key exclusion criteria (13 listed)
- previous history of gastrectomy
- ulcerative scar around ampulla of duodenum on endoscopy
- previous history of upper abdomen surgery (open)
- Emergency
- Severe ischemic heart disease
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 |
|---|---|---|
| Hand-sewnDoudenojejunal anastomosis by hand-sewn method | Procedure or surgery | I (Hand-sewn group) |
| Hemi-double staplingDoudenojejunal anastomosis by hemi-double-stapling method "EEA25 - Covidien EEA Circular Stapler DST Series 25.0mm x 4.8mm" is used for anastomosis | Procedure or surgery | II (Stapling group) |
Primary outcome
Grade of delayed gastric emptying by ISGPS
Time frame: At postoperative 21 day
Delayed gastric emptying will be evaluated at postoperative 21 day using International study group of pancreatic surgery (ISGPS) classification. According to ISGPS classification, delayed gastric emptying is divided into three grades from A to C. Grade C means worse than grade A.-->Unit of Measure: Grade A,B,C
1 secondary outcome
hospital stay
Time frame: At postoperative 21 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- 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.
Joon Seoung Park principal investigator
GangnamSeverance 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 Hand-sewn and Hemi-double stapling in people with Periampullar Disease, run by Gangnam Severance 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 5 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 25 Oct 2022. 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 Joon Seoung Park (82-2-2019-2444, jspark330@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade of delayed gastric emptying by ISGPS (time frame: At postoperative 21 day). 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 25 Oct 2022.