NKI Therapy Compared to Usual Care of Recurrent Esophagogastric Anastomotic Strictures

NCT04406428 | Terminated DMC

• 1 other identifier: NL65652.091.18
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: The study hypothesizes that NKI followed by endoscopic bougie dilation therapy will result in an increased dysphagia-free period, a reduction of endoscopic procedures and dysphagia-related quality of life, and lower costs, when compared with the standard endoscopic bougie dilation (EBD) in recurrent esophagogastric anastomotic strictures. Objective: To evaluate the efficacy and cost-effectiveness of needle-knife incision (NKI) followed by EBD compared to standard EBD in patients with recurrent esophagogastric anastomotic strictures. Study design: This multicenter study is an randomized controlled trial in which NKI followed by EBD will be compared with standard EBD. Study population: Patients with recurrent dysphagia (at least 1 and a maximum of 5 previous dilations) due to an anastomotic esophagogastric stricture that requires treatment with repeated endoscopic bougie dilations. Intervention : The intervention to be investigated is the addition of NKI therapy to EBD to 18 mm esophageal diameter. Main study parameters/endpoints: The primary outcome of this study will be EBD-free time during follow-up of 6 months. Secondary outcome parameters will be the number of endoscopic procedures for treatment of dysphagia, quality of life (QoL), cost-reduction and cost-effectiveness.

Conditions

Esophageal Stricture; Anastomotic Stenosis; Dilation of Esophagus Due to Disease

Outcome Measures

Primary Outcomes (1)

• Dilation free time

  EBD-free time

  6 months

Secondary Outcomes (4)

• Endoscopic procedures

  6 months

• QoL

  6 months

• Cost-reduction

  6 months

• Cost-effectiveness

  6 months

Study Arms (2)

NKI followed by EBD

EXPERIMENTAL

Procedure: NKI followed by EBD

Standard EBD

NO INTERVENTION

Interventions

NKI followed by EBD PROCEDURE

Needle-knife incision therapy followed by endoscopic bougie dilation

NKI followed by EBD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recurrent intra- or extrathoracic benign esophagogastric anastomotic stricture after esophagectomy. The definition of a stricture is based on the Ogilvie Dysphagia score (severity of dysphagia), i.e. Ogilvie score ≥2 (= ability to swallow semi-solid food or worse (Appendix table 1)).
• No patency for a standard endoscope (diameter \< 10 mm)
• The recurrent stricture has been previously treated with at least 1 to a maximum of 5 EBD sessions that reached an esophageal diameter of ≥16 mm.
• The stricture should be suitable for endoscopic incision (stricture length ≤10 mm).

You may not qualify if:

• Benign esophageal stricture other than an esophagogastric anastomotic stricture.
• Strictures with a morphology unsuitable for NKI, such as long (\>1 cm), irregulair or tortuous strictures.
• Previous endoscopic treatment of the esophageal stricture with steroid injection, incision therapy or stent placement within the past 3 months.
• Previous stent placement post-esophagectomy for anastomotic leakage.
• (Suspicion of) locally recurrent or metastasized esophageal cancer.
• Persisting postoperative esophageal fistula.
• Inability to discontinue anticoagulants or high-dose antiplatelet drugs at time of the baseline procedure. Low-dose aspirin (max. 100 mg/day) may be continued.
• Known clotting disorder that cannot pre-procedural be corrected.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Erasmus Medical Center: collaborator
• The Netherlands Cancer Institute: collaborator
• Leiden University Medical Center: collaborator
• UMC Utrecht: collaborator

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

MeSH Terms

Conditions

Esophageal Stenosis

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: May 28, 2020
• Study Start: September 14, 2020
• Primary Completion: February 20, 2024
• Study Completion: February 20, 2024
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)