Efficacy of Hemi-double-stapling Technique

NCT ID: NCT05088564

Last Updated: 2022-10-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-23
• Study Completion Date: 2024-04-22

Brief Summary

Surgical stapler is used in all areas of surgical operation. Surgical stapler has been used in various surgical fields for a long time, so its stability has already been proven. After gastrectomy or colectomy, the hemi-double stapling technique, which is an improved double stapling technique, has been applied as an anastomosis method using a stapler.

In the duodenojejunal anastomosis after PPPD, the hemi-double stapling method can be applied to preserve the pyloric branch of the vagus nerve and the branch of the right gastric artery to ensure sufficient blood supply. Ultimately, it is expected to shorten the anastomosis time as well as reduce the frequency of delayed gastric emptying. In addition, the work of physically expanding the pylorus to insert the circular anastomosis is also thought to reduce gastric emptying delay.

Detailed Description

(1) Stapling technique

1. Make purse-string suture on jejunum at the point of duodenojejunostomy

2. Insert Anvil into jejunem

3. Make incision of 3-4 centimeters at anterior side of antrum

4. Long Kelly forceps are inserted into the stomach to dilate the pylorus

5. A 25 mm end-to-end anastomosis (EEA) stapler is inserted into the stomach and passed through the pylorus.

6. The needle of EEA stapler is pierced through the lower part of the stapler line where the duodenum has been resected

7. The EEA stapler is combined with the anvil and anastomosis is performed

8. The incision on the stomach is sutured through a linear stapler

9. Reinforcement suture for stapler line

(2) Postoperative management

• Diet build up as same manner of hand-sewn group (3) Postoperative follow-up
• All postoperative complication, delayed gastric emptying, intraperitoneal abscess, postoperative pancreatic fistula, postpancreatectomy hemorrhage, hospital stay, reoperation, readmission and 2-months mortality.

Conditions

Periampullar Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

I (Hand-sewn group)

Doudenojejunal anastomosis by hand-swen method

Group Type: EXPERIMENTAL

Hand-sewn

Intervention Type: PROCEDURE

Doudenojejunal anastomosis by hand-sewn method

II (Stapling group)

Doudenojejunal anastomosis by hemi-double-stapling method

Group Type: ACTIVE_COMPARATOR

Hemi-double stapling

Intervention Type: PROCEDURE

Doudenojejunal anastomosis by hemi-double-stapling method "EEA25 - Covidien EEA Circular Stapler DST Series 25.0mm x 4.8mm" is used for anastomosis

Interventions

Hand-sewn

Doudenojejunal anastomosis by hand-sewn method

Intervention Type: PROCEDURE

Hemi-double stapling

Doudenojejunal anastomosis by hemi-double-stapling method "EEA25 - Covidien EEA Circular Stapler DST Series 25.0mm x 4.8mm" is used for anastomosis

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. pylorus-preserving pancreaticoduodenectomy

2. ECOG scale 0-1

3. Age > 19

4. Appropriate organ function as below i.WBC : ≥2500 mm3, ≤14000 mm3 ii.Hemoglobin : ≥9.0 g/dL iii.Platelet : ≥100,000 mm3 iv.Total bilirubin : ≤2.0 mg/dL (except for occlusive jaundice) v.Creatinine : ≤2.0 mg/dL

5. patient who can understand and sign the informed consent

Exclusion Criteria

1. previous history of gastrectomy

2. ulcerative scar around ampulla of duodenum on endoscopy

3. previous history of upper abdomen surgery (open)

4. Emergency

5. Severe ischemic heart disease

6. Severe hepatic failure by liver cirrhosis or hepatitis

7. Severe respiratory failure that requires oxygene inhalation

8. Chronic renal failure that requires hemodialysis

9. Expecting combine resection of other organ

10. Immunosuppressive therapy

11. Accompanying cancer with potential for adverse events

12. Severe psychologic or neurologic disease

13. drug or alcohol addiction

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gangnam Severance Hospital

OTHER

Sponsor Role: lead

Responsible Party

Joon Seong Park

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joon Seoung Park

Role: PRINCIPAL_INVESTIGATOR

GangnamSeverance Hospital

Locations

Gangnam Severance Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Joon Seoung Park

Role: CONTACT

jspark330@yuhs.ac

82-2-2019-2444

Facility Contacts

JoonSeoung Park

Role: primary

JSPARK330@yuhs.ac

82-2-2019-2999

Other Identifiers

3-2021-0084

Identifier Type: -

Identifier Source: org_study_id