NCT02999451

Brief Summary

POEM is a new intervention for the treatment of achalasia and has been reported to relieve the dysphagia symptom effectively. Although the cost of POEM method is less than the method of Laparoscopic Heller Myotomy and Fundoplication, it is still of an economic burden for the patients with achalasia. In this trial, investigators plan to use snare to assist POEM procedure, to observe the safety, efficacy and cost-effectiveness of this method, compared with other knifes-assisted procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

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

November 29, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

June 30, 2020

Status Verified

June 1, 2020

Enrollment Period

2.7 years

First QC Date

November 29, 2016

Last Update Submit

June 26, 2020

Conditions

Esophageal Achalasia

Keywords

Peroral endoscopic myotomySnareEndoscopic knifeEsophageal Achalasia

Outcome Measures

Primary Outcomes (1)

  • Clinical success rates

    Clinical success is defined as a post-POEM Eckardt score ≤3 without additional treatment (Eckardt AJ et al, Nat Rev Gastroenterol Hepatol 2011).

    12 months after treatment

Secondary Outcomes (12)

  • Procedure-related adverse events

    baseline to 12 months after treatment

  • Procedure time

    POEM procedure

  • The volume of intraoperative bleeding

    POEM procedure

  • The use of hemostatic forceps

    POEM procedure

  • Postoperative pain requiring the use of tramadol

    Through hospital stay after procedure, an average of 2-7 days

  • +7 more secondary outcomes

Study Arms (2)

snare group

EXPERIMENTAL

snare-assisted POEM

Device: snare-assisted POEM

conventional group

ACTIVE COMPARATOR

knife-assisted POEM

Device: knife-assisted POEM

Interventions

snare-assisted POEMDEVICE

POEM is performed by using a snare which is retracted into the sheath to expose the tip, leaving a 1-2mm length for operation. 1. After submucosal injection, an initial 2-cm mucosal incision is made by a snare in the posterior esophageal wall. 2. A submucosal tunnel from the esophagus to the gastric cardia is created using a snare. 3. Full-thickness myotomy is performed and extended 2-3 cm beyond the esophagogastric junction (EGJ) using a snare. 4. The mucosal incision is closed with endoclips.

snare group
knife-assisted POEMDEVICE

POEM is performed by using a conventional endoscopic knife. 1. After submucosal injection, an initial 2-cm mucosal incision is made by a knife in the posterior esophageal wall. 2. A submucosal tunnel from the esophagus to the gastric cardia is created using a knife. 3. Full-thickness myotomy is performed and extended 2-3 cm beyond the esophagogastric junction (EGJ) using a knife. 4. The mucosal incision is closed with endoclips.

conventional group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18-70 years
  • Diagnosed as achalasia base on high resolution manometry, barium esophagram and Upper endoscopy
  • Signed written informed consent

You may not qualify if:

  • ASA class \> Ⅲ
  • Previous endoscopic or surgical treatment for achalasia
  • Esophageal malignancy
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Xiangbin Xing, MD, PhD

    First Affiliated Hospital, Sun Yat-Sen University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 29, 2016

First Posted

December 21, 2016

Study Start

May 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

June 30, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)