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A prospective, single-blind, randomised controlled study to evaluate the adjunctive value of an outer casing in the preoperative clearance of intra-oesophageal retention in patients with pancreatic achalasia undergoing POEM

A prospective, single-blind, randomised controlled study to evaluate the adjunctive value of an outer casing in the preoperative clearance of intra-oesophageal retention in patients with pancreatic achalasia undergoing POEM

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089220
Enrollment
Unknown
Registered
2024-09-04
Start date
2024-10-01
Completion date
Unknown
Last updated
2024-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

achalasia

Interventions

Experimental group (A):Removal of retained material using the outer casing assist device
Control group (B):Routine endoscopic flushing of the oesophagus to remove retained material from the digestive tract

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: A.Patients with pancreatic achalasia who underwent POEM surgery. B.At preoperative endoscopy, the visibility of the lower oesophagus was scored and the oesophagus was inadequately prepared (oesophageal visibility score =3) patients. The oesophageal visibility score was as follows: C. Signed informed consent for clinical research.

Exclusion criteria

Exclusion criteria: A, Contraindications to POEM: patients with severe fibrosis of the submucosal layer of the oesophagus unable to establish a submucosal tunnel, significant inflammation of the lower oesophagus or gastro-oesophageal junction, and giant ulcers. B, Previous gastric or oesophageal surgery. C, Changes in physiological and anatomical conditions that make suction tube insertion impossible. D, Combination of severe coagulation disorders, severe cardiopulmonary diseases, poor general condition, etc. cannot tolerate surgery. E, The affected party refused to participate in the study. F, Study participants have been included in other clinical studies.

Design outcomes

Primary

MeasureTime frame
Adequate oesophageal preparation;Oesophageal visibility score before and after clearance;Clearing time;

Secondary

MeasureTime frame
Incidence of adverse events in both groups;POEM surgery status and patient prognosis related indicators;POEM surgery time;

Countries

China

Contacts

Public ContactKai Deng

West China Hospital, Sichuan University

dengkai11111@qq.com+86 189 8060 6867

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026