Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

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Symptoms and General Pathology

Rare Diseases

Pancreatic Neoplasms

Cholangiocarcinoma

Choledochal Cyst

Calculi

Gallstones

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Cholecystolithiasis

Cysts

Gastrointestinal Diseases

Adenocarcinoma

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Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pathological Conditions, Anatomical

Bile Duct Diseases

Biliary Tract Diseases

Congenital Abnormalities

Digestive System Abnormalities

Gallbladder Diseases

Pancreatic Cancer

Bile Duct Cancer

Bile Duct Cysts

A magnetic device will be used during bilioenteric anastomosis.

A handsewn technique will be used during bilioenteric anastomosis.

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

Magnetic Compressive Anastomosis

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

Manual Anastomosis

Yi Lv, MD,PHD

Xu-Feng Zhang, MD, PhD

Yi Lv, MD，PHD

Rongfeng Wang, MD

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

The 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. This study is a prospective, randomized controlled trial. To evaluate the security, reliability and convince of magnetic compressive bilioenteric anastomosis versus traditional suture method on incidence of anastomotic leakage and stricture between magnetic compressive anastomosis and traditional manual anastomosis among patients who need bilioenteric anastomosis operation. The study is to enroll about 200 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.

Bilioenteric Anastomosis by Magnetic Compressive Technique

Bilioenteric Anastomosis by Magnetic Compressive Technique: A Prospective, Randomized Controlled Trial

To compare the incidence of biliary leakage after magnetic or hand-sewn anastomosis

To compare the anastomotic time between magnetic and hand-sewn groups

To confirm the safe discharge of the magnets

To compare the length of stay between magnetic and hand-sewn groups

To compare the long-term outcome between magnetic and hand-sewn groups

Health Science Center of Xi'an Jiaotong University

Northwest Institute for Non-ferrous Metal Research

First Affiliated Hospital Xi'an Jiaotong University

Klatskin Tumor

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

Xiaopeng Yan, PHD

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.

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.

Superior Bilioenteric Anastomosis by Magnetic Compressive Technique

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

Shaanxi Provincial People's Hospital

Tang-Du Hospital

First Affiliated Hospital, Sun Yat-Sen University

First Affiliated Hospital of Xinjiang Medical University

General Hospital of Ningxia Medical University

Gallbladder Neoplasms

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gallbladder Cancer

Cholecystectomy is amongst the most common surgical operations performed worldwide. Surgical candidates are treated for biliary pathologies, such as biliary colic, cholecystitis and gallstone pancreatitis. In patients who are deemed fit for surgery, cholecystectomy can be performed under three main settings: (1) emergency setting at index admission; (2) elective setting with no previous admissions; or (3) delayed setting with one or more previous gallbladder-related admissions.

The advent of laparoscopy fundamentally evolved biliary surgery and quickly became the "gold standard" approach. Recent multicentre collaborative studies have elucidated that the burden imposed on healthcare systems by laparoscopic cholecystectomies is primarily due to patient readmissions and complications arising from the operation, rather than perioperative mortality burden that was more commonly seen in open surgery. As a result, national and international societies have shifted their focus towards creating a culture of safety around this procedure, with the overarching goal of improving patient satisfaction and reducing hospital costs. The universal establishment of safe cholecystectomy is a complex process that relies not only on the operation itself, but also on various other factors such as promoting adequate training, improving hospital infrastructure, and enhancing perioperative patient care.

There remains a paucity of evidence around the variations of safe provision of laparoscopic surgery for gallbladder disease internationally, including low- and middle-income countries. To bridge this knowledge gap, the Global Evaluation of Cholecystectomy Knowledge and Outcomes (GECKO) study (GlobalSurg 4) will be an international collaborative effort, delivered by the GlobalSurg network, that will allow contemporaneous data collection on the quality of cholecystectomies using measures covering infrastructure, care processes and outcomes. It will be disseminated via contacts from the National Institute for Health and Care Research (NIHR) Global Surgery unit, leading emergency general surgeons and specialist organisations.

Global Evaluation of Cholecystectomy Knowledge and Outcomes

Compliance to audit standards are defined as follows:

1. Pre-operative: For patients with acute cholecystitis, surgeons may use the Tokyo Guidelines 18.
2. Intraoperative: The use of the critical view of safety during laparoscopic cholecystectomy is the recommended approach to correctly identify relevant anatomy and minimize the risk of bile duct injuries
3. Postoperative: 30-day readmission should be \<10%.

The quality will be assessed according to the rates of overall complications defined as the presence of Grade I to grade V Clavien-Dindo complication.

Occurence of bile duct injury within 30-days of surgery will be defined according to the Strasberg Classification

The rates of gallbladder cancer will be assessed at 1-year from the index surgery once the histology results are available.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bilioenteric Anastomosis by Magnetic Compressive Technique	NCT03774589	Pancreatic Canc... Cholangiocarcin... Bile Duct Injur... Choledochal Cys... Biliary Calculi	Magnetic Compre... Manual Anastomo...	18 Years - 75 Years	First Affiliated Hospital Xi'an Jiaotong University
Bilioenteric Anastomosis by Magnetic Compressive Technique	NCT03774589	Pancreatic Canc... Cholangiocarcin... Bile Duct Injur... Choledochal Cys... Biliary Calculi	Magnetic Compre... Manual Anastomo...	18 Years - 75 Years	First Affiliated Hospital Xi'an Jiaotong University
Superior Bilioenteric Anastomosis by Magnetic Compressive Technique	NCT02801500	Hilar Cholangio... Bile Duct Injur... Choledochal Cys... Biliary Calculi	Magnetic Compre... Manual Anastomo...	18 Years - 75 Years	First Affiliated Hospital Xi'an Jiaotong University
Global Evaluation of Cholecystectomy Knowledge and Outcomes	NCT06223061	Gallstone Gallbladder Can... Bile Duct Injur...		18 Years - 100 Years	University of Edinburgh

Spots Global Cancer Trial Database for bile duct injury