Clinical trial NCT04479111: Laparoscopic IIeocecus-Sparing Right Hemicolectomy for Cancer of the Hepatic Flexure and Proximal Transverse Colon
Official title: An Open, Single-arm, Single Center, Clinical Trial to Investigate the Feasibility and Safety of Laparoscopic Ileocecus-sparing Right Hemicolectomy for Cancer of the Hepatic Flexure and Proximal Transverse Colon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Flexure Colon Cancer
Proximal Transverse Colon Cancer
Keywords: hepatic flexure colon cancer
proximal transverse colon cancer
ileocecus-sparing
laparoscopic right hemicolectomy
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate whether laparoscopic ileocecus-sparing right hemicolectomy is feasible and oncologically safe

Detailed description: Our study is a single arm, single center clinical trial. The enrolled patients will accept laparoscopic ileocecus-sparing right hemicolectomy. The primary endpoint: postoperative complications, 1-year local recurrence. The second endpoint: conversion to conventional right hemicolectomy, time to first flatus after surgery, number of harvested lymph nodes, 3-year disease free survival, R0 resection, Specimen morphometry

Eligibility criteria: Inclusion Criteria:

1. Patients suitable for curative surgery 18-75years old
2. ASA grade I-III
3. Qualitative diagnosis: a pathological diagnosis of adenocarcinoma;
4. Localization diagnosis: the tumor located at hepatic flexure and proximal transverse colon(proximal to the right branch of middle colic artery);
5. Enhanced CT scan of chest, abdominal and pelvic cavity: assessment of tumor stage is T1-T4N0 or TanyN+; there is no distant metastasis.
6. Intraoperative measurement: the distance between colic branch of ileocolic artery and proximal edge of the tumor should be longer than 5cm.
7. Informed consent

Exclusion Criteria:

1. Simultaneous or metachronous multiple primary colorectal cancer;
2. History of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.
3. Preoperative imaging examination results show: fused lymph node at the root of ileocolic artery.
4. Distant metastasis.
5. History of any other malignant tumor in recent 5 years.
6. Patients need emergency operation.
7. Not suitable for laparoscopic surgery (i.e., extensive adhesion caused by abdominal surgery, not suitable for artificial pneumoperitoneum, etc).
8. Informed consent refusal

Primary outcomes:
measure: Postoperative complications
timeFrame: up to 90 days after surgery
measure: 1-year local recurrence
timeFrame: 7 days after surgery
Secondary outcomes:
measure: Conversion to conventional right hemicolectomy
timeFrame: 1 day of surgery
measure: Time to first flatus after surgery
timeFrame: up to 7 days after surgery
measure: Number of harvested lymph nodes
timeFrame: up to 1 week after surgery
measure: R0 resection
timeFrame: up to 1 week after surgery
measure: Specimen morphometry
timeFrame: within 30 days
measure: 3-year disease free survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: KeFeng Ding, PhD
role: PRINCIPAL_INVESTIGATOR
References: