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Hilar CholangiocarcinomaCTREGNCT02801500

Superior Bilioenteric Anastomosis by Magnetic Compressive Technique

A study testing Magnetic Compressive Anastomosis and Manual Anastomosis in people with Hilar Cholangiocarcinoma and Bile Duct Injury, run by First Affiliated Hospital Xi'an Jiaotong University at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine whether the magnetic compressive anastomosis has a better outcomes than traditional manual anastomosis on superior bilioenteric anastomosis. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Magnetic Compressive Anastomosis and Manual Anastomosis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
2 sitesChina
Study dates
1 Jul 2017to Jun 2019
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 superior bilioenteric 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 hepatic 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.

Yi Lv, MD,PHD contact

0086-13991200581

luyi169@126.com

China2 sites, 2 recruiting

  • First Affiliated Hospital of Xian JiaotongUniversity

    Xi'an, Shaanxi, 710061

    Yi Lv, MD，PHD, 0086-13991200581, luyi169@126.com

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

    Xiaopeng Yan, PHD, 08615332432878, yanxiaopeng99@163.com

    Recruiting

Other trials in China

About this study

Official title: Superior Bilioenteric Anastomosis by Magnetic Compressive Technique: A Multicenter, Prospective, Randomized Controlled Trial

The purpose of this study is to determine whether the magnetic compressive anastomosis has a better outcomes than traditional manual anastomosis on superior bilioenteric anastomosis.

Read the detailed description

The superior bilioenteric anastomosis is one of the most common and difficult operations in Hepatobiliary Surgery. The traditional manual anastomosis has become one of the main prognosis factors because of the length of suture time, the difficulty of operation, the high incidence of anastomotic leakage and stricture. Magnetic compressive anastomosis can realize the fast anastomosis, reduce the difficulty, and reduce the incidence of anastomotic leakage and stricture. Currently, the majority of studies of magnetic compressive bilioenteric anastomosis are merely confined within clinical case report and single-center, small sample, retrospective study, thus they are lack of convictive evidence of evidence-based medicine for the security, reliability and convince.

This study is a multicenter, prospective, randomized controlled trial. To evaluate the security, reliability and convince of magnetic compressive superior bilioenteric anastomosis, this study compared the incidence of anastomotic leakage and stricture between magnetic compressive anastomosis and traditional manual anastomosis among patients who need superior bilioenteric anastomosis operation. The study design plan to enroll 70 patients and divide into Study Group (Group A: Magnetic compressive anastomosis) and Control Group (Group B: traditional manual anastomosis) as 1:1 ratio randomly by stratification factors. The incidence of anastomotic leakage and stricture, length of bilioenteric anastomosis time, value of serum bilirubin, length of discharge time of magnetic device and mean time of hospital stay will be evaluated. The patients will drop out of the study if adverse events happen, active request for dropping out, new-onset severe disease or death. The primary and secondary end point will be observed by regular follow-up.

Being tested
Magnetic Compressive Anastomosis, Manual Anastomosis
Keywords
bilioenteric anastomosis
Medical subject headings
Klatskin Tumor, Choledochal Cyst, Gallstones

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnetic Compressive AnastomosisDevice

    The magnetic compressive anastomosis device will be used to complete the anastomosis during bilioenteric anastomosis.

  • Manual AnastomosisProcedure or surgery

    A handsewn technique will be used to complete the anastomosis during bilioenteric anastomosis.

Study groups in NCT02801500
Study groupRoleWhat they receive
Magnetic Compressive AnastomosisExperimentalA magnetic device will be used during bilioenteric anastomosis.
Receives: Device: Magnetic Compressive Anastomosis
Traditional Manual AnastomosisActive comparatorA handsewn technique will be used during bilioenteric anastomosis.
Receives: Procedure: Manual Anastomosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bilioenteric anastomotic leakage

    Measured: 1 month post operation

Secondary outcomes (6)

  1. Length of bilioenteric anastomosis time

    Measured: during operation

  2. Number of patients who have discharged the device on the date expected.

    Measured: 1 to 4 weeks postoperation

  3. Number of patients who have been diagnosed as discharge disorder of magnetic device

    Measured: less than 1 week or more than 4 weeks

  4. average length of postoperative hospital stay

    Measured: 3 months

  5. Times of pathological examination of bile duct's remnant of Klatskin' tumor

    Measured: during operation

  6. Bilioenteric anastomotic stricture

    Measured: Time Frame: 1,3,6,12-month post operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2016 (estimated)
  2. Study start1 Jul 2017
  3. Primary completionJun 2018 (estimated)
  4. Study completionJun 2019 (estimated)

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02801500
Sponsor's protocol ID
XJTU1AF-CRF-2015-001
Acronym
CTREG
Status last verified
Sep 2017
First submitted
29 May 2016
Last updated
21 Sep 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Sicklick JK, Camp MS, Lillemoe KD, Melton GB, Yeo CJ, Campbell KA, Talamini MA, Pitt HA, Coleman J, Sauter PA, Cameron JL. Surgical management of bile duct injuries sustained during laparoscopic cholecystectomy: perioperative results in 200 patients. Ann Surg. 2005 May;241(5):786-92; discussion 793-5. doi: 10.1097/01.sla.0000161029.27410.71.

    PubMed 15849514

  • House MG, Cameron JL, Schulick RD, Campbell KA, Sauter PK, Coleman J, Lillemoe KD, Yeo CJ. Incidence and outcome of biliary strictures after pancreaticoduodenectomy. Ann Surg. 2006 May;243(5):571-6; discussion 576-8. doi: 10.1097/01.sla.0000216285.07069.fc.

    PubMed 16632990

  • Frattaroli FM, Reggio D, Guadalaxara A, Illomei G, Pappalardo G. Benign biliary strictures: a review of 21 years of experience. J Am Coll Surg. 1996 Nov;183(5):506-13.

    PubMed 8912621

  • Yan JQ, Peng CH, Ding JZ, Yang WP, Zhou GW, Chen YJ, Tao ZY, Li HW. Surgical management in biliary restricture after Roux-en-Y hepaticojejunostomy for bile duct injury. World J Gastroenterol. 2007 Dec 28;13(48):6598-602. doi: 10.3748/wjg.v13.i48.6598.

    PubMed 18161934

  • Avaliani M, Chigogidze N, Nechipai A, Dolgushin B. Magnetic compression biliary-enteric anastomosis for palliation of obstructive jaundice: initial clinical results. J Vasc Interv Radiol. 2009 May;20(5):614-23. doi: 10.1016/j.jvir.2009.01.019.

    PubMed 19393505

  • Chopita N, Vaillaverde A, Cope C, Bernedo A, Martinez H, Landoni N, Jmelnitzky A, Burgos H. Endoscopic gastroenteric anastomosis using magnets. Endoscopy. 2005 Apr;37(4):313-7. doi: 10.1055/s-2005-861358.

    PubMed 15824939

  • Stepanov EA, Vasil'ev GS, Nikolaev VV. [The treatment of intestinal fistulae in children by applying a by-pass anastomosis using magnetic devices]. Khirurgiia (Mosk). 1992 Nov-Dec;(11-12):93-5. Russian.

    PubMed 1294807

  • Fan C, Ma J, Zhang HK, Gao R, Li JH, Yu L, Wu Z, Lv Y. Sutureless intestinal anastomosis with a novel device of magnetic compression anastomosis. Chin Med Sci J. 2011 Sep;26(3):182-9. doi: 10.1016/s1001-9294(11)60046-1.

    PubMed 22207929

Questions about this trial

What is this clinical trial studying?

A study testing Magnetic Compressive Anastomosis and Manual Anastomosis in people with Hilar Cholangiocarcinoma and Bile Duct Injury, 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 21 Sep 2017. 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?

Bilioenteric anastomotic leakage (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?

On the ClinicalTrials.gov record for NCT02801500, which also lists 8 linked publications.

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 Sep 2017.

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