Safety & Efficacy of a Novel Asymmetrical Linear Stapler (NALS) for Securing Distal Resection Margin in Laparoscopic Rectal Cancer Surgery: Pilot Study

Through the use of a novel asymmetrical linear stapler (NALS, Meditulip co. Ltd.), we aim to prove that true distal margins greater than 1cm may be harvested more readily and easily compared to the conventional staplers. The study is designed as a pilot RCT of 30 patients in each group, with the primary outcome of distal margin length >1cm. Secondary outcomes include anastomosis dehiscence and time taken to harvest the distal margin.

Study Overview

• Status: Not yet recruiting
• Conditions: Colo-rectal Cancer
• Intervention / Treatment: Device: Novel asymmetrical linear stapler; Device: Signia™

Detailed Description

Current evidence indicates distal margins of greater than 1cm from the tumor is necessary for superior oncologic outcomes. In middle to lower rectal cancer, where the tumor is close to the anus, sparing the anus whilst securing such a margin may prove difficult.

Failure to secure sufficient margin length may end up in cancer recurrence, but inaccurate assessment of the margin status may also cause further unnecessary resection or failure to spare the anus.

The novel asymmetrical linear stapler was designed specifically with this problem in mind, and one row of stapling was removed from the specimen side to allow easier harvesting of a undisrupted distal margin tissue for pathological evaluation.

This study is a pilot RCT of 30 patients each in the novel stapler group and control group, to prove the non-inferiority in safety and superiority in harvesting the distal margin (assessed by length of margin and time to harvest).

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jae Hyun Park, MD; Phone Number: +82 10 7233 3820; Email: parkjhyun719@naver.com
• Study Contact Backup: Name: Seung-Bum Ryoo, MD PhD; Email: sbryoomd@gmail.com

Study Locations

• Korea, Republic of
  • Jongro-gu
    • Seoul, Jongro-gu, Korea, Republic of, 03080
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Rectal cancer patients between the age of 19~79, who require anus preserving laparoscopic rectum resection surgery

Exclusion Criteria:

• Advanced rectal cancer that invades surrounding structures or has known distant metastasis
• Uncontrolled comorbidities
• Patients otherwise considered unsuitable for the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Novel asymmetrical linear stapler; Rectal cancer patients randomized to this group will use the novel asymmetrical linear stapler for distal rectum transection, and with 2 rows of stapler lines instead of 3, sufficient tissue is left on the specimen side to harvest the true distal margin for accurate pathological evaluation.	Device: Novel asymmetrical linear stapler; Novel asymmetrical linear stapler
Active Comparator: Control; Rectal cancer patients in the control group will use the conventional Signia™ stapler (Medtronic co.) as routinely used in the centers involved with the study, which has triple stapling technology (3 rows of stapler lines on both sides of transection)	Device: Signia™; Signia™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
True distal margin length > 1cm	True distal margin: The length of tissue from the distal edge of the specimen to the distal tumor margin in the surgical specimen	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early anastomosis leakage	Anastomosis leakage within 30 days of surgery will be documented and reported as an outcome. The International Study Group of Rectal Cancer definition of anastomosis leakage will be used to define the outcome (defect of the intestinal wall at the anastomotic site leading to a communication between the intra- and extraluminal compartments, requiring NPO or other intervention). Patients that have clinical signs of infection (fever, sepsis, inflammatory lab change or abdominal drain color change) with either fluid collection near the anastomosis or an anastomosis defect on CT imaging will be diagnosed as having anastomosis leakage. CT scans will not be taken routinely, but will be performed when signs of infection (such as abdominal tenderness or high fever) are present. Severity of the anastomosis leak will be graded according to the International Study Group of Rectal Cancer grading system (grade A, B, C) depending on the necessary intervention (none, non-surgical or surgical).	From randomization until the date of first documented sign of leakage, assessed up to 30 days
Time to harvest margin	Time (seconds) taken to harvest the distal margin from the specimen for frozen section biopsy	Intraoperative (from the beginning of frozen section specimen harvest until the acquirement is completed. This process will be timed by a member of the surgical team using a timer.)
Specimen integrity	The pathologist evaluation of whether the whole thickness of bowel was harvested in the distal margin frozen section biopsy. This will be requested and reviewed, reported in the final pathologist report.	Intraoperative (at the time point of the frozen section pathology report)
Sphincter preservation rate	Although all eligible candidates will be planned for sphincter-preserving surgery, there are some cases where the distal margin is not suffice for an R0 resection and thus receive non-sphincter preserving surgery. The incidence of such non-sphincter preserving surgery (example: abdominoperineal resection) will be reported.	From randomization until the end of clinical data collection, assessed up to 120 days.

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: National Cancer Center, Korea; Seoul National University Bundang Hospital; Seoul National University Boramae Hospital; Kyungpook National University Chilgok Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: November 17, 2024
• First Submitted That Met QC Criteria: November 27, 2024
• First Posted (Actual): November 29, 2024

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Rectal cancer; Frozen sections; Margins of Excision
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Rectal Neoplasms
• Other Study ID Numbers: 2023-3198

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No