Pancreatic NeoplasmsMCTPIANCT03780946
Magnetic Compressive Technique for Pancreatic Intestinal Anastomosis
An observational study of Pancreatic Neoplasms and Pancreatitis, Chronic, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
In recent five years, the investigators have successfully developed different types of magnets and utilized in biliojejunostomy, concomitant biliojejunostomy and pancreaticojejunostomy during Whipple. This study is designed as a prospective study by utilization of the bar-like magnets for pancreaticojejunostomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pancreatic Neoplasms, Pancreatitis, Chronic
- What is being tested?
- Magnetic anastomosis for pancreaticojejunostomy and Traditional hand-sewn anastomosis
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2019to 31 Jan 2022
- How long will I take part?
- 3 Months
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Patients with pancreatic neoplasm who needs pancreatic head resection, or central pancreatectomy or partial pancreatectomy, and then pancreaticojejunostomy. 2. Patients with dilated pancreatic duct secondary to chronic pancreatitis who needs Frey's procedure. 3. Patients with pancreatic injury who needs pancreatic head resection, or central pancreatectomy or partial pancreatectomy, and then pancreaticojejunostomy. 4. Patients who are willing to join this clinical trial and informed consent form voluntarily.
Who may be able to join
- Patients with pancreatic neoplasm who needs pancreatic head resection, or central pancreatectomy or partial pancreatectomy, and then pancreaticojejunostomy
- Patients with dilated pancreatic duct secondary to chronic pancreatitis who needs Frey's procedure
- Patients with pancreatic injury who needs pancreatic head resection, or central pancreatectomy or partial pancreatectomy, and then pancreaticojejunostomy
Who cannot join
- Woman during pregnancy or lactation or anyone with mental disorder
- The wall of pancreatic incision is too thick so that the attractive force of magnetic device cannot meet the requirements of compression
- Any foreign body has been implanted in body, such as heart pacemaker.
- Surgical contraindication, including Child-Pugh C with hepatic encephalopathy, and anyone with heart, lung, kidney dysfunction or other organ dysfunction, and cannot tolerate surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Xu-Feng Zhang, MD, PhD, 86 29 85323900, xfzhang125@126.com
About this study
In recent five years, the investigators have successfully developed different types of magnets and utilized in biliojejunostomy, concomitant biliojejunostomy and pancreaticojejunostomy during Whipple. This study is designed as a prospective study by utilization of the bar-like magnets for pancreaticojejunostomy.
Read the detailed description
Magnetic anastomosis has been attempted in continuous connection between bowel and bowel, vessels and vessels, biliary and gastrointestinal tracts, as well as in recanalization of the biliary stricture, and bilioenteric anastomotic stricture. During the past 15 years, the investigators have designed different types of magnets, and attempted these magnets in vascular, intestine, and biliary anastomosis in preclinical studies. In recent five years, we have successfully developed different types of magnets and utilized in biliojejunostomy, concomitant biliojejunostomy and pancreaticojejunostomy during Whipple. This study is designed as a prospective study by utilization of the bar-like magnets for pancreaticojejunostomy.
- Conditions
- Pancreatic Neoplasms, Pancreatitis, Chronic
- Being tested
- Magnetic anastomosis for pancreaticojejunostomy, Traditional hand-sewn anastomosis
- Keywords
- magnamosis; magnetic anastomosis; pancreaticojejunostomy
- Medical subject headings
- Pancreatic Neoplasms, Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic anastomosis for pancreaticojejunostomyProcedure or surgery
Magnetic anastomosis for pancreaticojejunostomy
Traditional hand-sewn anastomosisProcedure or surgery
Traditional manual anastomosis for pancreaticojejunostomy
| Study group | Role | What they receive |
|---|---|---|
| Magnetic group | Magnetic anastomosis for pancreaticojejunostomy Receives: Procedure: Magnetic anastomosis for pancreaticojejunostomy | |
| Control group | Traditional hand-sewn for pancreaticojejunostomy Receives: Procedure: Traditional hand-sewn anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreatic fistula
Leakage of pancreatic fistula, which is defined according to Clinically relevant Pancreatic fistula (PF) was defined by the International Study Group of Pancreatic Surgery in 2016: a drain output of any measurable volume of fluid with an amylase level >3 times the upper limit of institutional normal serum amylase activity.
Measured: From date of surgery to one month postoperatively
Secondary outcomes (2)
Anastomotic stricture
Anastomotic stricture, which will be verified by imaging studies or endoscopic investigations
Measured: one year from the date of surgery
Discharge of the magnets
X-ray plain film is performed regularly to check the movement and discharge of the magnets
Measured: 3 months from the date of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Feb 2019
- Primary completion31 Jan 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Lv, MD, PhD, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780946
- Sponsor's protocol ID
- XJTU1AF-CRF-2015-001-3
- Acronym
- MCTPIA
- Status last verified
- Nov 2019
- First submitted
- 12 Dec 2018
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Compressive Technique for Pancreatic Intestinal Anastomosis
- ClinicalTrials.gov ID
- NCT03780946
- Acronym / sponsor ID
- MCTPIA / XJTU1AF-CRF-2015-001-3
- Conditions
- Pancreatic Neoplasms, Pancreatitis, Chronic
- Keywords
- magnamosis; magnetic anastomosis; pancreaticojejunostomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 19 Dec 2018 (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.
In recent five years, the investigators have successfully developed different types of magnets and utilized in biliojejunostomy, concomitant biliojejunostomy and pancreaticojejunostomy during Whipple. This study is designed as a prospective study by utilization of the bar-like magnets for pancreaticojejunostomy.
Detailed description
Magnetic anastomosis has been attempted in continuous connection between bowel and bowel, vessels and vessels, biliary and gastrointestinal tracts, as well as in recanalization of the biliary stricture, and bilioenteric anastomotic stricture. During the past 15 years, the investigators have designed different types of magnets, and attempted these magnets in vascular, intestine, and biliary anastomosis in preclinical studies. In recent five years, we have successfully developed different types of magnets and utilized in biliojejunostomy, concomitant biliojejunostomy and pancreaticojejunostomy during Whipple. This study is designed as a prospective study by utilization of the bar-like magnets for pancreaticojejunostomy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnetic group | – | Procedure: Magnetic anastomosis for pancreaticojejunostomyMagnetic anastomosis for pancreaticojejunostomy |
| Control group | – | Procedure: Traditional hand-sewn anastomosisTraditional hand-sewn for pancreaticojejunostomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Patients with pancreatic neoplasm who needs pancreatic head resection, or central pancreatectomy or partial pancreatectomy, and then pancreaticojejunostomy. 2. Patients with dilated pancreatic duct secondary to chronic pancreatitis who needs Frey's procedure. 3. Patients with pancreatic injury who needs pancreatic head resection, or central pancreatectomy or partial pancreatectomy, and then pancreaticojejunostomy. 4. Patients who are willing to join this clinical trial and informed consent form voluntarily.
Key inclusion criteria (3 listed)
- Patients with pancreatic neoplasm who needs pancreatic head resection, or central pancreatectomy or partial pancreatectomy, and then pancreaticojejunostomy
- Patients with dilated pancreatic duct secondary to chronic pancreatitis who needs Frey's procedure
- Patients with pancreatic injury who needs pancreatic head resection, or central pancreatectomy or partial pancreatectomy, and then pancreaticojejunostomy
Key exclusion criteria (4 listed)
- Woman during pregnancy or lactation or anyone with mental disorder
- The wall of pancreatic incision is too thick so that the attractive force of magnetic device cannot meet the requirements of compression
- Any foreign body has been implanted in body, such as heart pacemaker.
- Surgical contraindication, including Child-Pugh C with hepatic encephalopathy, and anyone with heart, lung, kidney dysfunction or other organ dysfunction, and cannot tolerate surgery
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 |
|---|---|---|
| Magnetic anastomosis for pancreaticojejunostomyMagnetic anastomosis for pancreaticojejunostomy | Procedure or surgery | Magnetic group |
| Traditional hand-sewn anastomosisTraditional manual anastomosis for pancreaticojejunostomy | Procedure or surgery | Control group |
Primary outcome
Pancreatic fistula
Time frame: From date of surgery to one month postoperatively
Leakage of pancreatic fistula, which is defined according to Clinically relevant Pancreatic fistula (PF) was defined by the International Study Group of Pancreatic Surgery in 2016: a drain output of any measurable volume of fluid with an amylase level >3 times the upper limit of institutional normal serum amylase activity.
2 secondary outcomes
Anastomotic stricture
Time frame: one year from the date of surgery
Discharge of the magnets
Time frame: 3 months from the date of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
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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.
Yi Lv, MD, PhD principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Neoplasms and Pancreatitis, Chronic, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site 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 3 inclusion and 4 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 13 Nov 2019. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lv Yi, MD, PhD (86-29-85323900, luyi169@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pancreatic fistula (time frame: From date of surgery to one month postoperatively). 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 13 Nov 2019.