RecruitingNot ApplicableNCT06280469

Single-operator Versus Two-operator Technique in Single-balloon Enteroscopy

Single-operator Versus Two-operator Technique in Single-balloon Enteroscopy: a Prospective, Multicenter, Non-inferiority Randomized Controlled Trial


Sponsor

Shuhui Liang

Enrollment

206 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Compared to two-operator single-balloon enteroscopy, single-operator procedure not only offer better maneuverability but may also prevent prolonged examination times and potential complications caused by poor coordination between operators. Additionally, it can optimize staffing in the endoscopy suite. However, there are no studies comparing the effects of single-operator and two-operator techniques on single-balloon enteroscopy.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • age greater than eighteen years;
  • suspected small bowel disease with planned enteroscopy

Exclusion Criteria7

  • patients with a history of small bowel surgery;
  • patients who fail to perform bowel preparation as required;
  • patients with existing esophageal varices at high risk of bleeding;
  • patients not requiring a deep small-bowel examination, such as those with lesions clearly localized to the proximal jejunum, or terminal ileum;
  • patients who are in extremely poor physical condition and are not suitable for general anesthesia, as defined by an ASA score greater than 3;
  • pregnant or lactating women;
  • patients unable to provide written informed consent.

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Interventions

PROCEDURESingle-Balloon Enteroscopy

Insertion procedure of single-balloon enteroscopy. (1) Insert the scope. (2) Angulate the scope to hold the gut and deflate the balloon. (3) Advance the splinting tube. (4) Inflate the balloon. (5) Withdraw both the scope and splinting tube while releasing the angulation. (6) Withdraw both the scope and splinting tube to shorten the intestine. (7) Repeat these steps until the scope reaches the deep part of the small bowel.


Locations(6)

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

The Second Hospital & Clinical Medical School, Lanzhou University

Lanzhou, Gansu, China

The Fifth Affiliated Hospital of Zunyi Medical University

Zhuhai, Guangdong, China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shannxi, China

Xi'an Honghui Hospital

Xi'an, Shannxi, China

Xijing Hospital of Digestive Diseases

Xi'an, Shannxi, China

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NCT06280469