NCT03701464

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 10, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

October 10, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

1.7 years

First QC Date

October 5, 2018

Last Update Submit

July 12, 2020

Conditions

Success Rate

Keywords

ERCPPTGBDENGBDGallbladder drainageCholecystitis

Outcome Measures

Primary Outcomes (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.

    3 weeks

Secondary Outcomes (8)

  • Gallbladder drainage success rate

    3 months

  • Migration

    3 months

  • Hemorrhage

    3 months

  • Perforation

    3 months

  • Bile leak

    3 months

  • +3 more secondary outcomes

Study Arms (2)

Endoscopic naso-gallbladder drainage

EXPERIMENTAL

After 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.

Procedure: Endoscopic naso-gallbladder drainage

Percutaneous gallbladder drainage

ACTIVE COMPARATOR

Ultrasound 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.

Procedure: Percutaneous gallbladder drainage

Interventions

Endoscopic naso-gallbladder drainagePROCEDURE

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

Endoscopic naso-gallbladder drainage
Percutaneous gallbladder drainagePROCEDURE

Percutaneous transhepatic technique insert drainage tube into gallbladder

Percutaneous gallbladder drainage

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, 730000, China

Location

Related Publications (6)

  • 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.

    PMID: 22245666BACKGROUND

  • 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.

    PMID: 25952093BACKGROUND

  • 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.

    PMID: 25527052BACKGROUND

  • 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.

    PMID: 27343412BACKGROUND

  • 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.

    PMID: 33385126DERIVED

  • 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.

    PMID: 32080085DERIVED

MeSH Terms

Conditions

Cholecystitis

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Xun Li, MD,PhD

    Hepatopancreatobiliary Surgery Institute of Gansu Province

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2018

First Posted

October 10, 2018

Study Start

October 10, 2018

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

July 14, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)