Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Diseases and Abnormalities at or Before Birth

Symptoms and General Pathology

Rare Diseases

Pancreatic Neoplasms

Cholangiocarcinoma

Choledochal Cyst

Calculi

Gallstones

Cholelithiasis

Cholecystolithiasis

Cysts

Gastrointestinal Diseases

Adenocarcinoma

Carcinoma

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

Dilatation, Pathologic

Central Nervous System Depressants

All Drugs and Chemicals

Hematinics

Gastrointestinal Agents

Anesthetics

Liver Extracts

Pancrelipase

Pancreatin

After adequate general anesthesia, the non-3D group underwent conventional choledochal cyst excision surgery, while the 3D group underwent choledochal cyst excision surgery guided by three-dimensional visualization technology or enhanced reality navigation.

Three-dimensional reconstruction technology is a software that can collect CT and MRI data, perform image segmentation and three-dimensional reconstruction of the liver, gallbladder, dilated bile ducts, pancreas, venous, and arterial systems step by step. The software is called Abdominal Medical Image 3D Visualization Software (MI-3DVS, software copyright registration number: 2008SR18798).The AR-ANS (Software Copyright No.: 2018SR840555) is an intraoperative navigation system that integrates three-dimensional visualization technology.This modification provides visual guidance for surgeons when ligating or protecting critical vascular tissues during surgery.

Three-dimensional visualization technology

zeng ning, Doctor

cai peilin, master

This research discusses the clinical application value of augmented reality navigation technology combined with three-dimensional visualization technology in improving surgical safety and promoting the development of precision surgery. This technology can reduce intraoperative vascular and bile duct injuries, effectively avoid serious postoperative complications, and reduce residual cysts.

Choledochal cysts (CC) have traditionally been considered as cystic dilatations of the extrahepatic bile duct. Choledochal cysts are now referred to as choledochal dilatation, which also includes intrahepatic and extrahepatic cysts. Choledochal cysts are defined as cystic dilatations involving the bile duct tree of single or multiple segments of the intrahepatic and extrahepatic bile ducts. In 1959, Alonso-Lej et al. first divided CC into 3 types based on the location of bile duct dilatation. It was not until 1977 that Todani et al. revised the classification, adding 2 more types of CCs, which is the most commonly used classification by clinicians today; however, some experts dispute this, claiming that each type of CC has its own natural history, complications, and treatments. It is suggested to focus more on the pathogenesis rather than a simple anatomical classification of the bile duct tree. Choledochal cysts are a rare anomaly and are sometimes considered as a precancerous condition, which often leads to diagnostic challenges. The typical presentation of this condition is nonspecific. Medical teams must have a high clinical suspicion of choledochal cysts when investigating patients with jaundice, abdominal pain, and palpable abdominal masses. Due to the ambiguity of these symptoms and physical examination findings, appropriate imaging studies are crucial for diagnosis. Resection of choledochal dilatation has shown excellent results, with a complication-free rate of 89% and an overall 5-year survival rate exceeding 90%. Therefore, early diagnosis and appropriate management are essential to achieve optimal outcomes and a good prognosis.

Clinical practice has confirmed that the modern digital imaging technology, such as three-dimensional visualization and augmented reality navigation technology, built for hepatobiliary surgery diagnosis and treatment platform plays a crucial guiding role in precise preoperative assessment, lesion localization, formulation of optimal surgical plans, and intraoperative navigation to avoid collateral damage. Professor Fang Chihua's team has conducted long-term research and breakthroughs in this field. A significant portion of the literature in the field of digital intelligent diagnosis and treatment technology retrieved from SinoMed - China Biomedical Literature Service System comes from Professor Fang Chihua's team. The team has published consecutive expert consensus in the Chinese Journal of Practical Surgery in the field of digital intelligence in hepatobiliary surgery, including the publication of "Expert Consensus on Precise Diagnosis and Treatment of Three-Dimensional Visualization of Hepatobiliary Stones (2019 Edition)," which affirms the significant impact of three-dimensional visualization technology in guiding the precise diagnosis and treatment of hepatobiliary stones. The "Consensus recommendations of three-dimensional visualization for diagnosis and management of liver disease" published in an international journal demonstrates that China's research level in this field is at the forefront globally. Sioh Huang Lim et al. utilized ICG intraoperative navigation technology to visualize the extrahepatic bile ducts without radiation, enabling quicker identification of bile ducts compared to cholangiography. Liu Yangsui et al. applied fluorescence imaging technology for real-time navigation of the extrahepatic bile ducts, achieving superior outcomes in terms of surgical time, intraoperative blood loss, and postoperative hospital stay compared to the traditional surgery group. In laparoscopic re-exploration of the bile duct, Tian Guangjin et al. used ICG fluorescence navigation technology as surgical assistance, with a conversion to open surgery rate of approximately 3.3% in the navigation group compared to 22.9% in the conventional surgery group, achieving higher rates of minimally invasive abdominal surgery in the navigation group. Takeshi Aoki et al. indicated in their literature the successful staining of subsegments or liver segments in 33 out of 35 cases (94.3%) using fluorescence imaging technology for liver resection navigation. Kunshan He et al. demonstrated that near-infrared (NIR) imaging method resulted in less blood loss and shorter hospital stay compared to traditional methods. ICG fluorescence imaging technology has shown promising prospects in partial liver resection surgery. In conclusion, three-dimensional visualization technology can achieve precise preoperative differentiation of vascular variations, formulate individualized surgical plans based on reconstructed three-dimensional models, and provide real-time navigation during surgery to ensure the success of the operation. Intraoperative real-time augmented reality technology navigation helps prevent intraoperative bile duct injuries, effectively reduce severe postoperative complications, and decrease residual cysts and associated complications. Therefore, the combined application of both technologies in the treatment of choledochal cysts surgery provides better medical technological support, enhances surgical safety and precision, promotes the development of minimally invasive surgery, and holds significant clinical value.

The Application of Digital Intelligent Diagnostic and Therapeutic Technology in Biliary Dilation Diagnosis

Navigating the Biliary Maze：a Retrospective Cohort Study of Augmented Reality Improving Outcomes in Choledochal Dilation Resection

Comprehensive Complication Index:integrating all recorded complications weighted by severity in a single formula.

Zhujiang Hospital

This was a retrospective review of all paediatric patients who had undergone an IVGT graft procedure for biliary tract anatomical obstruction in the past five years. We looked at the indications for surgery, the demographic profile of the patients, outcomes following surgery and outlined the surgical technique used.

A conduit was created by tubularising a vascularized segment of the greater curve of the antrum of the stomach and this was used between the remaining common hepatic duct and the duodenum.

Isolated Vascularized Gastric Tube (IVGT) graft

This was a retrospective case series experience of paediatric patients who had an Isolated vascularized gastric tube biliary enteric drainage procedure for biliary obstruction over the past five years. We reviewed our experience and outcomes.

Background

Despite the enormous surgical advancements in the last century, access to the biliary system is lost when a Roux-en-Y (RY) biliary drainage procedure is performed. Attempts have been made to overcome this inconvenient sequel of RY biliary drainage by the use of variations in the RY anastomosis, small bowel grafts and vascular grafts. These have been predominantly unsuccessful. The use of an Isolated Vascularized Gastric Tube (IVGT) graft has been reported in the literature, and this was successfully used for adult patients with common bile duct injuries. The investigators have adopted the technique of using an IVGT graft for bile duct reconstruction in the paediatric patients at their institution.

Method

The investigators reviewed theirr experience at Greys Hospital, Pietermaritzburg. This was a retrospective review of all paediatric patients who had undergone an IVGT graft procedure for biliary tract anatomical obstruction in the past five years. The investgators looked at the indications for surgery, the demographic profile of the patients, outcomes following surgery and outlined the surgical technique used.

Isolated Vascularized Gastric Tube Biliary Enteric Drainage: A Paediatric Case Series Experience.

Data will be retained by researchers and ade available on request.

Effectiveness of procedure to allow drainage of bile into the bowel.

What complications were encountered following the procedure

University of KwaZulu

Head of Paediatric Surgery, Greys Hospital

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

Cholangitis

Choledocholithiasis

Common Bile Duct Diseases

Adjuvants, Anesthesia

Psychotropic Drugs

Analgesics

Midazolam

Ketamine

Hypnotics and Sedatives

Meperidine

Anesthetics, Dissociative

Anesthetics, Intravenous

Anesthetics, General

Excitatory Amino Acid Antagonists

Neurotransmitter Agents

Anti-Anxiety Agents

GABA Modulators

Analgesics, Opioid

Narcotics

Initial IV Ketamine of 0.5mg/kg with IV Midazolam 0.02mg/kg given over 1 minute. If depth of sedation not adequate, to give another bolus of IV ketamine 0.25mg/kg after 2 minutes with IV Midazolam 0.01mg/kg. If depth of sedation not adequate, to give another bolus of IV Ketamine 0.25mg/kg after 2 minutes and IV Midazolam 0.01mg/kg. Failure of sedation: inadequate sedation for the intention to treat: patient will be arranged for MAC (monitored anaesthesia care) with anaesthesia team

Initial IV Midazolam 0.05mg/kg given over 1 minute with IV Pethidine 0.7mcg/kg. If depth of sedation not If adequate, to give another bolus of IV Midazolam 0.02mg/kg after 2 minutes and IV Pethidine 0.7mcg/kg. If depth of sedation not adequate, to give another bolus of IV Midazolam 0.02mg/kg after 2 minutes. Failure of sedation: inadequate sedation for the intention to treat: patient will be arranged for MAC (monitored anaesthesia care) with anaesthesia team.

Administration described in arm/ group description

Pethidin

Rajdave Singh

Azlanudin Azman

Ian Chik

Jegan Thanabalan

Kanesh Kumar Doraisamy

Does Ketamine-Midazolam have a better efficacy and safety profile compared to Midazolam - Pethidine in Endoscopic Retrograde Cholangiopancreatography (ERCP)?

Ketamine- Midazolom is more efficacious in producing desired sedative state and have a better safety profile as a sedative agent in ERCP compared to Midazolam- Pethidine. The usage of sedative agent in ERCP depends on surgeon's preferences and availability of the drugs. The most commonly used sedatives in ERCP is Midazolam with pethidine. The use of Midazolam , however, is related to:

1. 20-45% failure of sedation during ERCP
2. Cardio-respiratory depression - apnoea: 15.4%, hypotension: 15.7%, bradycardia: 6.8%

Due to the proven efficacy and safety profile of ketamine-midazolam as a sedative agent in procedural sedation, the investigators propose that the use of ketamine-midazolam as a sedative agent in ERCP is more effective and better safety profile when compared to Midazolam- Pethidine. The synergistic effect means to reduce the total dose of midazolam used.

Patients will be randomized into the intervention or control group (Intervention group will receive Ketamine - Midazolam and control group will receive Midazolam- Pethidine as a sedative agent in ERCP

Care provider is blinded from knowing the group of the study. However patients are informed regarding the drugs received

Ketamine-midazolam as a Sedative Agent in Endoscopic Retrograde Cholangiopancreatography.

Combination Use of Intravenous Ketamine-midazolam as a Sedative Agent in Endoscopic Retrograde Cholangiopancreatography ; A Randomized Control Trial

Sedation failure rate is defined as inability of the sedation used to adequately sedate a patient for initiation and completion of procedure using ramsay sedation scale where the scale is 1 to 6, where higher score is better. Score of 1 is determined as sedation failure.

To detect if there are changes in MAP calculated from participants blood pressure readings

Adverse event by monitoring patient vital signs including blood pressure, pulse rate, oxygen saturation and procedure will be abandoned if the parameters reach a pre-set cut-off point.

Systolic blood pressure \<90mmHg or \>180mmHg, Pulse rate of \<60/min or \>150/min and oxygen saturation \<95% despite supplemental oxygen therapy via nasal canula.

The depth of sedation is evaluated using ramsay sedation scale where the scale is 1 to 6, where higher score is better

National University of Malaysia

Associate Professor

Infections

Immune System Diseases

Liver Cirrhosis

Hepatitis A

Hepatitis

Hepatitis, Autoimmune

Cholangitis, Sclerosing

Biliary Atresia

Fibrosis

Liver Diseases

Hepatitis, Chronic

Autoimmune Diseases

Autoimmune Hepatitis

Primary Sclerosing Cholangitis

Chronic Graft Versus Host Disease

The internal cohort was retrospectively enrolled in West China Hospital, Sichuan University from June 2010 and December 2020. It is a training and internal validation cohort.

The same inclusion/exclusion criteria were applied for the same center prospectively. It is a external validation cohort.

Clinical models were developed and validated to predict liver-related complications and survival outcomes in pediatric patients with biopsy-proven with cirrhosis.

Prediction model

Yuhan Yang, MD

The aim of this study was to developed and validated models to predict hepatic decompensation and survivals in pediatric patients with cirrhosis and compared these models with currently available models.

Noninvasive liver fibrosis tests such as the NAFLD fibrosis score (NFS), Hepascore, and transient elastography were specifically developed to predict fibrosis and can help predict patients with NAFLD at the highest risk of developing liver-related complications. These tests have been widely applied in adult cirrhosis. The accuracy of these models, however, may be influenced by patient factors including age, body mass index, and diabetes, potentially limiting their prognostic accuracy and clinical practicability in children. Therefore, it is currently unknown how to best predict hepatic decompensation and survival outcomes among pediatric patients with cirrhosis. To fill this knowledge gap, the investigators performed a retrospective-prospective cohort study with the aim of developing and validating a clinical model to predict liver-related complications and survival outcomes in pediatric patients with biopsy-proven with cirrhosis. Secondly, the investigators aimed to compare the predictive accuracy with currently available noninvasive model.

Predictive Models of Hepatic Decompensation and Survival Outcomes in Pediatric Patients With Cirrhosis

The primary outcome was the first event of hepatic decompensation, defined by the occurrence of any of the following: ascites (identified or confirmed by abdominal ultrasound), upper gastrointestinal bleeding secondary to portal hypertension (confirmed by endoscopy in the presence of gastroesophageal varices or portal hypertensive gastropathy), or hepatic encephalopathy (established by clinical parameters, neuropsychological tests, or electroencephalogram)

The endpoint was defined as the occurrence of death or the last follow-up. Patients were followed from the day of liver biopsy until the occurrence of death, liver transplant, or last visit. The outcome was evaluated by an experienced hepatologist in each center every 3-6 months. At each visit, a medical history, physical examination, and standard laboratory tests were performed.

West China Hospital

All patients received laparoscopic-assisted CDC excision and hepaticojejunostomy.

After birth, the liver and gallbladder ultrasound were regularly rechecked. If the maximum diameter of the cyst was greater than 5 cm, surgery was performed.

laparoscopic-assisted CDC excision and hepaticojejunostomy

xisi guan

In this prospective study, we tried to select the operation time according to the cyst size and evaluate the treatment effect.

A choledochal cyst (CDC) is a congenital anomaly of the biliary system, which is more common in the Asian population. If a CDC is not diagnosed and treated promptly, it often leads to a series of serious complications, including cholangitis, cyst rupture, cholestatic cirrhosis, and even cholangiocarcinoma. Infants with a postnatal diagnosis of CDC often present with symptoms, and to avoid the occurrence of serious complications, operative correction should be performed as soon as possible when their clinical conditions allow. However, in the current era with the improvement of prenatal screening technology, an increasing number of choledochal cysts are diagnosed prenatally in the fetus. In developed countries, as many as 15% of choledochal cysts are found before birth. Some of these children receive intervention when they are asymptomatic at an early stage, while some have progressed to CDC-related symptoms before operative correction. The timing of operation for children with a prenatal diagnosis of CDC remains controversial. The investigators previous study showed that it is more advantageous to receive surgical treatment in the asymptomatic period for patients with prenatally diagnosed CDC. In addition, the age at operation (months) appears to be unrelated to intraoperative and postoperative complications, which is distinct from previous studies. More interestingly, the investigators found that a specific cyst size (length \> 5.2 cm and width \> 4.1 cm) suggested that clinical symptoms might appear and that the surgery should be performed as soon as clinically safe to proceed. Therefore, in this study, the investigators tried to select the operation time according to the cyst size and evaluate the treatment effect.

Timing of Operation in Children With a Prenatal Diagnosis of Choledochal Cyst

Timing of Operation in Children With a Prenatal Diagnosis of Choledochal Cyst：A Single-center Prospective Study

number of participants progressed to CDC-related symptoms before operative intervention

number of participants with cyst rupture before operative intervention

number of participants with post-operative anastomotic leak

number of participants with postoperative hemorrhage

number of participants with postoperative wound infection

number of participants with anastomotic stricture

length of nutritional support in hospital

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
The Application of Digital Intelligent Diagnostic and Therapeutic Technology in Biliary Dilation Diagnosis	NCT06418490	Congenital Bili... Choledochal Cys...	Three-dimension...	16 Years - 75 Years	Zhujiang Hospital
Isolated Vascularized Gastric Tube Biliary Enteric Drainage: A Paediatric Case Series Experience.	NCT04319302	Biliary Obstruc... Choledochal Cys...	Isolated Vascul...	- 12 Years	University of KwaZulu
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
Ketamine-midazolam as a Sedative Agent in Endoscopic Retrograde Cholangiopancreatography.	NCT06111872	Cholangitis Pancreatic Canc... Choledocholithi... Choledochal Cys...	Ketamine Midazolam Pethidin	18 Years -	National University of Malaysia
Predictive Models of Hepatic Decompensation and Survival Outcomes in Pediatric Patients With Cirrhosis	NCT05181332	Cirrhosis Biliary Atresia Choledochal Cys... Primary Scleros... HBV HCV Autoimmune Hepa...	Prediction mode...	0 Years - 18 Years	West China Hospital
The Application of Digital Intelligent Diagnostic and Therapeutic Technology in Biliary Dilation Diagnosis	NCT06418490	Congenital Bili... Choledochal Cys...	Three-dimension...	16 Years - 75 Years	Zhujiang Hospital
Timing of Operation in Children With a Prenatal Diagnosis of Choledochal Cyst	NCT05620485	Choledochal Cys...	laparoscopic-as...	0 Months - 3 Months	Guangzhou Women and Children's Medical Center

Spots Global Cancer Trial Database for choledochal cyst