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Completed

NCT Number: NCT03701464

Comparison of ENGBD and PTGBD in Acute Suppurative Cholecystitis

Comparison of ENGBD and PTGBD methods on clinical outcomes and the difficulty of cholecystectomy in later stage in patients with acute suppurative cholecystitis.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, 730000, China

About this study

Laparoscopic cholecystectomy was the standard surgical method for acute cholecystitis unless difficulty in resection due to acute inflammation, no improvement after supportive therapy, or early inability to tolerate cholecystectomy. In this setting, gallbladder drainage was needed. Percutaneous transhepatic gallbladder drainage (PTGBD)was used as a first-line mitigation method, whose restrictions are contraindications and strong pain caused by puncture. Endoscopic technique based on endoscopic retrograde cholangiopancreatography (ERCP) had been made another alternative management for drainage. Endoscopic drainage expanded the indications for drainage without reducing the technical success rate and clinical remission rate, especially less uncomfortable, which greatly improved the quality of life for patients. Unfortunately, because of the difficult procedures and long learning curve, endoscopic gallbladder drainage can only be performed in some large endoscopic centers. Despite a few prospective comparison of PTGBD and endoscopic ultrasound EUS drainage studies so far, there is no prospective study comparing endoscopic naso-gallbladder drainage (ENGBD) and PTGBD, especially in its impacts while cholecystectomy. This study aim to observe clinical effects of ENGBD and PTGBD during the all stage of peri-cholecystectomy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute suppurative cholecystitis
  • Who can not tolerate or unsuitable for cholecystectomy

Exclusion criteria

  • Unwillingness or inability to consent for the study
  • Coagulation dysfunction (INR> 1.5) and low peripheral blood platelet count (<50×10^9 / L) or using anti-coagulation drugs
  • Bile duct stones
  • Prior surgery of Bismuth Ⅱ, Roux-en-Y and Cholangiojejunostomy
  • Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage or perforation, severe liver disease(such as decompensated liver cirrhosis, liver failure and so on), septic shock
  • Any malignant
  • Pregnant women or breastfeeding

Treatment and study plan

Endoscopic naso-gallbladder drainage

Procedure

Using ERCP technique insert a naso-gallbladder drainage tube through common bile duct and cystic duct.

Percutaneous Gallbladder Drainage

Procedure

Percutaneous transhepatic technique insert drainage tube into gallbladder

Primary outcomes

  1. Pain remission(visual-analogue scale)

    Time frame: 3 weeks

    Pain assessment would be performed using the visual-analogue scale after procedures. Draw a 10 cm line on a piece of paper, mark one end of the line with the nubmer 0, indicating no pain; the other end with 10, indicating severe pain; the middle part indicates different degrees of pain. While assesing the pain scale, make sure the patient can not see the numbers on the paper, and let them mark the position according to their feelings about the pain. And the physician will have a score based on the mark.

Secondary outcomes

  1. Gallbladder drainage success rate

    Time frame: 3 months

    Bile juice outflow more than 50ml a day

  2. Migration

    Time frame: 3 months

    Number of participants with tube dislocation from gallbladder

  3. Hemorrhage

    Time frame: 3 months

    Number of participants with bleeding which was defined as hemoglobin deceased, or required transfusion or additional intervention

  4. Perforation

    Time frame: 3 months

    Number of participants whose CT scan shows retroperitoneal or gallbladder space fluid or gas

  5. Bile leak

    Time frame: 3 months

    Number of participants with bile juice leak into abdomen

  6. Number of participants with Pancreatitis

    Time frame: 3 months

    Was defined as typical pain, Serum amylase at least three times than normal after EPCP

  7. Cholecystectomy duration

    Time frame: 3 months

    Time of laparoscopic cholecystectomy

  8. Hemorrhage during cholecystectomy

    Time frame: 3 months

    The amount of bleeding

Sponsors and collaborators

Lead sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province

Other

Registry information

Official study title

Comparison of Clinical Efficacy Between ENGBD and PTGBD in Acute Suppurative Cholecystitis: a Single-center, Prospective Randomized Trial

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 10, 2018
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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