CholangiocarcinomaNCT03792048
Magnetic Compressive Anastomosis for Biliojejunostomy and Pancreaticojejunostomy During Whipple's Procedure
A study testing Magnetic Compressive Anastomosis in people with Cholangiocarcinoma and Pancreatic Neoplasms, run by First Affiliated Hospital Xi'an Jiaotong University at 2 sites in China.
Trial summary
Magnetic anastomosis has been attempted in biliary and intestinal reconstruction. Based on our initial experience, the investigators have successfully utilized magnetic anastomosis for biliojejunostomy and pancreaticojejunostomy during pancreaticoduodenectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cholangiocarcinoma, Pancreatic Neoplasms, Duodenal Neoplasms
- What is being tested?
- Magnetic Compressive Anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesChina
- Study dates
- 1 Feb 2019to 31 Jan 2022
- 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 age between 18 to 75
- Patients' gender was not limited
- Patients who were well-diagnosed and had the indication for anastomosis.
- Patients whose lifetimes will be longer than 12 months.
- Patients who are willing to join this clinical trial and informed consent form voluntarily.
Who cannot join
- Woman during pregnancy or lactation or anyone with mental disorder
- The wall of biliary duct or jejunum was too thick so that the attractive force of magnetic device cannot meet the requirements of compression.
- Any anatomical variation in bile ducts system or the inner diameter is too small so that the magnetic device cannot place in.
- Any foreign body has been implanted in body, such as heart pacemaker.
- Surgical contraindication, including:
- Child-Pugh C with hepatic encephalopathy Anyone with heart, lung, kidney dysfunction or other organ dysfunction, and cannot tolerate surgery.Hepatic ducts stone disease, who was diagnosed as Acute Cholangitis of Severe Type, especially complicated with bacteremia or septic shock. End stage disease, complicated with biliary cirrhosis or portal hypertension.Patients with long-term obstructive jaundice, dehydration, electrolyte disturbance or coagulation defects; Patients have the tendency or history of bleeding.
- -Any other disease in perioperation periods which needs MRI examination in the next 8 weeks post operation.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
First Affiliated Hospital of Xian JiaotongUniversity
Xi'an, Shaanxi, 710061
Yi Lv, MD，PHD, 0086-13991200581, luyi169@126.com
Zhe Feng, MD, 0086-17749083602, 624779797@qq.com
- 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
Official title: Magnetic Compressive Anastomosis for Biliojejunostomy and Pancreaticojejunostomy During Whipple's Procedure: a Prospective Case-control Study
Magnetic anastomosis has been attempted in biliary and intestinal reconstruction. Based on our initial experience, the investigators have successfully utilized magnetic anastomosis for biliojejunostomy and pancreaticojejunostomy during pancreaticoduodenectomy. The current study was to design a prospective and case-control study with utilization of magnetic compression anastomosis for pancreaticojejunostomy and biliojejunostomy in Whipple's procedure versus traditional hand-sewn technique on the postoperative morbidity, such as biliary/pancreatic fistula, hemorrhage, anastomotic stenosis, etc. In addition, the investigators are seeking to assess the safety and formation of the anastomosis by magnetic technique.
Read the detailed description
The magnets used in the current study consists of a mother and daughter magnets. An 8-Fr nasogastric tube is tightly fixed with the mother magnet, which will be used for bile or pancreatic drainage before formation of anastomoses. The outside diameter (OD) of the magnets ranges from 5mm to 15mm. In fact, for biliojejunostomy, larger magnets are applied, whereas for pancreaticojejunostomy, smaller magnets are routinely used. This study is a single-center, parallel controlled trial to evaluate the safety and effectiveness of magnetic compression technique for biliojejunostomy and pancreaticojejunostomy, versus traditional hand-sewn techniques on the postoperative morbidity of the patients. And also how to avoid mutual attraction of the two pairs of magnets, formation of bilio-/pancreaticojejunostomy time, discharge rule of the magnets will be all evaluated in the current study.
- Conditions
- Cholangiocarcinoma, Pancreatic Neoplasms, Duodenal Neoplasms, Pancreatolithiasis, Chronic Pancreatitis
- Being tested
- Magnetic Compressive Anastomosis
- Keywords
- bilioenteric anastomosis, pancreaticojejunostomy, Magnetic Compressive
- Medical subject headings
- Cholangiocarcinoma, Pancreatic Neoplasms, Duodenal Neoplasms, Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Compressive AnastomosisProcedure or surgery
A magnetic device will be used during bilioenteric anastomosis and pancreaticojejunostomy
| Study group | Role | What they receive |
|---|---|---|
| Magnetic Compressive Anastomosis | Experimental | A magnetic device will be used during bilioenteric anastomosis and pancreaticojejunostomy Receives: Procedure: Magnetic Compressive Anastomosis |
| Manual Anastomosis | No intervention | Manual Anastomosis for bilioenteric anastomosis and pancreaticojejunostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of anastomotic fistula
Incidence of biliary or pancreatic fistula after surgery
Measured: 1 month post operation
Secondary outcomes (5)
Length of bilio-/pancreaticojejunostomy time
Separate operation time of magnetic anastomosis for bilio- and pancreaticojejunostomy
Measured: during operation
average length of postoperative hospital stay
length of hospital stay (days) after surgery
Measured: 1 to 4 weeks postoperation
Hospitalization cost
cost in hospital
Measured: 1 to 4 weeks postoperation
incidence of biliojejunostomic stricture
Incidence of biliojejunostomic stricture between magnetic and manual groups during the relatively long-term follow-up
Measured: 12 months post operation
Incidence of pancreaticojejunostomic stricture
Incidence of pancreaticojejunostomic stricture between magnetic and manual groups during the relatively long-term follow-up
Measured: 12 months post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- 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 CholangiocarcinomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
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
- NCT03792048
- Sponsor's protocol ID
- XJTU1AF-CRF-2015-001-2
- Status last verified
- Nov 2019
- First submitted
- 12 Dec 2018
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- 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 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Compressive Anastomosis for Biliojejunostomy and Pancreaticojejunostomy During Whipple's Procedure: a Prospective Case-control Study
- ClinicalTrials.gov ID
- NCT03792048
- Acronym / sponsor ID
- XJTU1AF-CRF-2015-001-2
- Conditions
- Cholangiocarcinoma, Pancreatic Neoplasms, Duodenal Neoplasms, Pancreatolithiasis, Chronic Pancreatitis
- Keywords
- bilioenteric anastomosis, pancreaticojejunostomy, Magnetic Compressive
- Study type
- Interventional
- 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
- 3 Jan 2019 (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.
Magnetic anastomosis has been attempted in biliary and intestinal reconstruction. Based on our initial experience, the investigators have successfully utilized magnetic anastomosis for biliojejunostomy and pancreaticojejunostomy during pancreaticoduodenectomy. The current study was to design a prospective and case-control study with utilization of magnetic compression anastomosis for pancreaticojejunostomy and biliojejunostomy in Whipple's procedure versus traditional hand-sewn technique on the postoperative morbidity, such as biliary/pancreatic fistula, hemorrhage, anastomotic stenosis, etc. In addition, the investigators are seeking to assess the safety and formation of the anastomosis by magnetic technique.
Detailed description
The magnets used in the current study consists of a mother and daughter magnets. An 8-Fr nasogastric tube is tightly fixed with the mother magnet, which will be used for bile or pancreatic drainage before formation of anastomoses. The outside diameter (OD) of the magnets ranges from 5mm to 15mm. In fact, for biliojejunostomy, larger magnets are applied, whereas for pancreaticojejunostomy, smaller magnets are routinely used. This study is a single-center, parallel controlled trial to evaluate the safety and effectiveness of magnetic compression technique for biliojejunostomy and pancreaticojejunostomy, versus traditional hand-sewn techniques on the postoperative morbidity of the patients. And also how to avoid mutual attraction of the two pairs of magnets, formation of bilio-/pancreaticojejunostomy time, discharge rule of the magnets will be all evaluated in the current study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnetic Compressive Anastomosis | Experimental | Procedure: Magnetic Compressive AnastomosisA magnetic device will be used during bilioenteric anastomosis and pancreaticojejunostomy |
| Manual Anastomosis | No intervention | –Manual Anastomosis for bilioenteric anastomosis and pancreaticojejunostomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with age between 18 to 75
- Patients' gender was not limited
- Patients who were well-diagnosed and had the indication for anastomosis.
- Patients whose lifetimes will be longer than 12 months.
- Patients who are willing to join this clinical trial and informed consent form voluntarily.
Key exclusion criteria (7 listed)
- Woman during pregnancy or lactation or anyone with mental disorder
- The wall of biliary duct or jejunum was too thick so that the attractive force of magnetic device cannot meet the requirements of compression.
- Any anatomical variation in bile ducts system or the inner diameter is too small so that the magnetic device cannot place in.
- Any foreign body has been implanted in body, such as heart pacemaker.
- Surgical contraindication, including:
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 Compressive AnastomosisA magnetic device will be used during bilioenteric anastomosis and pancreaticojejunostomy | Procedure or surgery | Magnetic Compressive Anastomosis |
Primary outcome
Incidence of anastomotic fistula
Time frame: 1 month post operation
Incidence of biliary or pancreatic fistula after surgery
5 secondary outcomes
Length of bilio-/pancreaticojejunostomy time
Time frame: during operation
average length of postoperative hospital stay
Time frame: 1 to 4 weeks postoperation
Hospitalization cost
Time frame: 1 to 4 weeks postoperation
incidence of biliojejunostomic stricture
Time frame: 12 months post operation
Incidence of pancreaticojejunostomic stricture
Time frame: 12 months post operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- 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.
Yi Lv, MD, PhD principal investigator
First Affiliated Hospital Xi'an Jiaotong University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Compressive Anastomosis in people with Cholangiocarcinoma and Pancreatic Neoplasms, run by First Affiliated Hospital Xi'an Jiaotong University 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 5 inclusion and 7 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 18 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 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. 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 Yi Lv, MD,PHD (0086-13991200581, luyi169@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of anastomotic fistula (time frame: 1 month post operation). 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 18 Nov 2019.