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Success RateNCT03701464

Comparison of ENGBD and PTGBD in Acute Suppurative Cholecystitis

A study testing Endoscopic naso-gallbladder drainage and Percutaneous gallbladder drainage in people with Success Rate, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Success Rate
What is being tested?
Endoscopic naso-gallbladder drainage and Percutaneous gallbladder drainage
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteChina
Study dates
10 Oct 2018to 1 Jul 2020
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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Hepatopancreatobiliary Surgery Institute of Gansu Province

    Lanzhou, Gansu, 730000

Other trials in China

About this study

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

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

Read the detailed description

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.

Conditions
Success Rate
Being tested
Endoscopic naso-gallbladder drainage, Percutaneous gallbladder drainage
Keywords
ERCP, PTGBD, ENGBD, Gallbladder drainage, Cholecystitis
Medical subject headings
Cholecystitis

What participants receive

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

  • Endoscopic naso-gallbladder drainageProcedure or surgery

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

  • Percutaneous gallbladder drainageProcedure or surgery

    Percutaneous transhepatic technique insert drainage tube into gallbladder

Study groups in NCT03701464
Study groupRoleWhat they receive
Endoscopic naso-gallbladder drainageExperimentalAfter selective bile duct cannulation, a 0.025- or 0.035-inch guidewire is advanced into the cystic duct and subsequently into the gallbladder. A 5F naso- Pancreas catheter was inserted into the gallbladder for ENGBD.
Receives: Procedure: Endoscopic naso-gallbladder drainage
Percutaneous gallbladder drainageActive comparatorUltrasound guided，an 18-gauge needle is inserted into the gallbladder，0.035 inch guidewire is coiled into the gallbladder and 9Fr dilator expands the skin,then 8Fr-20cm catheter is placed.
Receives: Procedure: Percutaneous gallbladder drainage

What is being measured

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

  1. Pain remission（visual-analogue scale）

    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.

    Measured: 3 weeks

Secondary outcomes (8)

  1. Gallbladder drainage success rate

    Bile juice outflow more than 50ml a day

    Measured: 3 months

  2. Migration

    Number of participants with tube dislocation from gallbladder

    Measured: 3 months

  3. Hemorrhage

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

    Measured: 3 months

  4. Perforation

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

    Measured: 3 months

  5. Bile leak

    Number of participants with bile juice leak into abdomen

    Measured: 3 months

  6. Number of participants with Pancreatitis

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

    Measured: 3 months

  7. Cholecystectomy duration

    Time of laparoscopic cholecystectomy

    Measured: 3 months

  8. Hemorrhage during cholecystectomy

    The amount of bleeding

    Measured: 3 months

Timeline

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

  1. First posted10 Oct 2018
  2. Study start10 Oct 2018
  3. Primary completion1 Jul 2020
  4. Study completion1 Jul 2020

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
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03701464
Sponsor's protocol ID
ENGBD in acute cholecystitis
Status last verified
Jul 2020
First submitted
5 Oct 2018
Last updated
14 Jul 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jang JW, Lee SS, Song TJ, Hyun YS, Park DY, Seo DW, Lee SK, Kim MH, Yun SC. Endoscopic ultrasound-guided transmural and percutaneous transhepatic gallbladder drainage are comparable for acute cholecystitis. Gastroenterology. 2012 Apr;142(4):805-11. doi: 10.1053/j.gastro.2011.12.051. Epub 2012 Jan 11.

    PubMed 22245666

  • Kedia P, Sharaiha RZ, Kumta NA, Widmer J, Jamal-Kabani A, Weaver K, Benvenuto A, Millman J, Barve R, Gaidhane M, Kahaleh M. Endoscopic gallbladder drainage compared with percutaneous drainage. Gastrointest Endosc. 2015 Dec;82(6):1031-6. doi: 10.1016/j.gie.2015.03.1912. Epub 2015 May 5.

    PubMed 25952093

  • Itoi T, Kawakami H, Katanuma A, Irisawa A, Sofuni A, Itokawa F, Tsuchiya T, Tanaka R, Umeda J, Ryozawa S, Doi S, Sakamoto N, Yasuda I. Endoscopic nasogallbladder tube or stent placement in acute cholecystitis: a preliminary prospective randomized trial in Japan (with videos). Gastrointest Endosc. 2015 Jan;81(1):111-8. doi: 10.1016/j.gie.2014.09.046.

    PubMed 25527052

  • Khan MA, Atiq O, Kubiliun N, Ali B, Kamal F, Nollan R, Ismail MK, Tombazzi C, Kahaleh M, Baron TH. Efficacy and safety of endoscopic gallbladder drainage in acute cholecystitis: Is it better than percutaneous gallbladder drainage? Gastrointest Endosc. 2017 Jan;85(1):76-87.e3. doi: 10.1016/j.gie.2016.06.032. Epub 2016 Jun 22.

    PubMed 27343412

  • Mu P, Lin Y, Zhang X, Lu Y, Yang M, Da Z, Gao L, Mi N, Li T, Liu Y, Wang H, Wang F, Leung JW, Yue P, Meng W, Zhou W, Li X. The evaluation of ENGBD versus PTGBD in high-risk acute cholecystitis: A single-center prospective randomized controlled trial. EClinicalMedicine. 2020 Dec 23;31:100668. doi: 10.1016/j.eclinm.2020.100668. eCollection 2021 Jan.

    PubMed 33385126

  • Mu P, Yue P, Li T, Bai B, Lin Y, Zhang J, Wang H, Liu Y, Yao J, Meng W, Li X. Comparison of endoscopic naso-gallbladder drainage and percutaneous transhepatic gallbladder drainage in acute suppurative cholecystitis: Study Protocol Clinical Trial (SPIRIT Compliant). Medicine (Baltimore). 2020 Feb;99(8):e19116. doi: 10.1097/MD.0000000000019116.

    PubMed 32080085

Questions about this trial

What is this clinical trial studying?

A study testing Endoscopic naso-gallbladder drainage and Percutaneous gallbladder drainage in people with Success Rate, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 1 site 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 2 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: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain remission（visual-analogue scale） (time frame: 3 weeks). 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 NCT03701464, which also lists 6 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 14 Jul 2020.

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