Comparison of Drainage Methods in Minimally Invasive Esophagectomy (DEMURE)

NCT ID: NCT07004634

Last Updated: 2025-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2026-08-01

Brief Summary

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This RCT compares three drainage approaches after minimally invasive esophagectomy (chest tube + thoracic mediastinal drainage tube, thoracic, and abdominal mediastinal drainage tube) to evaluate perioperative outcomes, addressing current evidence gaps in pain and complication profiles.

Detailed Description

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Conditions

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Esophageal Cancer Drainage/Methods Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Abdominal mediastinal tube

Transperitoneal mediastinal drainage was performed for postoperative management of the patient.

Group Type EXPERIMENTAL

Abdominal mediastinal tube

Intervention Type PROCEDURE

Transperitoneal mediastinal drainage was performed for postoperative management of the patient.

Chest mediastinal tube

Transthoracic mediastinal drainage was performed for postoperative management of the patient.

Group Type EXPERIMENTAL

Chest mediastinal tube

Intervention Type PROCEDURE

Transthoracic mediastinal drainage was performed for postoperative management of the patient.

Chest tube + chest mediastinal tube

Chest tube insertion combined with transthoracic mediastinal drainage was performed for postoperative management of the patient.

Group Type EXPERIMENTAL

Chest tube + chest mediastinal tube

Intervention Type PROCEDURE

Chest tube insertion combined with transthoracic mediastinal drainage was performed for postoperative management of the patient.

Interventions

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Chest mediastinal tube

Transthoracic mediastinal drainage was performed for postoperative management of the patient.

Intervention Type PROCEDURE

Abdominal mediastinal tube

Transperitoneal mediastinal drainage was performed for postoperative management of the patient.

Intervention Type PROCEDURE

Chest tube + chest mediastinal tube

Chest tube insertion combined with transthoracic mediastinal drainage was performed for postoperative management of the patient.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years
* Pathologically confirmed esophageal cancer requiring three-incision esophagectomy (cervical, thoracic, and abdominal incisions)
* ASA physical status class I-III

Exclusion Criteria

* History of chronic pain or long-term use of analgesics prior to surgery
* Severe cardiopulmonary dysfunction (e.g., FEV1 \<50%)
* Coagulation disorders or patients undergoing reoperation
* Intraoperative findings of extensive pleural adhesions, combined resection of adjacent organs, or other conditions deemed by the investigator to warrant exclusion
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hecheng Li, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

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Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hecheng Li, PhD, MD

Role: CONTACT

00862164370045 ext. 664566

Wangyang Meng, MD

Role: CONTACT

00861592767592

Facility Contacts

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Dingpei Han, PhD, MD

Role: primary

00862164370045 ext. 666112

Other Identifiers

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RTS-026

Identifier Type: -

Identifier Source: org_study_id

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