Open Versus Laparoscopic Assisted Pancreaticoduodenectomy

Pancreas Neoplasm Clinical Trial

Official title:

Open Versus Laparoscopic Assisted Pancreaticoduodenectomy: Randomized Control Comparative Prospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05463328
• Other study ID #: pancreaticoduodenectomy
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: July 2022
• Source: Assiut University
• Contact: mohammed aly ahmed, Assist.lecturer
• Phone: 01067575588
• Email: mohamed1234ali1991[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Compare open and laparoscopic assisted pancreaticoduodenectomy regarding intraoprative blood loss, organ injury, completion of planned laparoscopic steps, duration and early post operative course of pain, hem stability, oral feeding, leakage(pancreatic, billary and intestinal). ,bleeding, mortality, lymph nodes and safety margins .

Description:

Pancreaticoduodenectomy is the only option curative intended in the treatment of resectable pancreatic ductal adenocarcinomas, duodenal carcinoma, ampullary carcinoma, lower common bile duct cholangiocarcinoma,. It is still associated with very high morbidity and mortality. [1]. Pancreatic cancer ranks as the seventh leading cause of cancer-related death worldwide, and the fourth among other cancers[2,3]. In recent years, the minimally invasive techniques has considered revolution in surgeries of pancreatic cancers [4,5]. Laparoscopic assisted pancreaticoduodenectomy is a hybrid procedure combining laparoscopic resection and reconstruction through a small incision.it companies laparoscopic mobilization and dissection due to magnification compared with open pancreaticoduodenectomy[6]. Several studies have shown that laparoscopic assisted pancreaticoduodenectomy could result in less blood loss less, pain ,less wound infection and shorter hospital stay compared to open pancreaticoduodenectomy[7,8]. Limited literature described the safety and efficacy of laparoscopic assisted pancraticododenostomy .Also such comparative studies deficient in evaluation of outcomes of laparoscopic assisted pancraticododenostomy and open pancraticoduodenoctomy.So the interest of our study is to compare between the feasibility and safety of laparoscopic assisted pancraticododenostomy and open pancraticoduodenoctomy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. age less than 70 years.

2. resectable tumour,

3. fit for surgery

Exclusion Criteria:

1. patients with jaundice with serum bilirubin above 200mml/dl.

2. patients with bleeding tendency until corrected.

3. patients with advanced and metastatic malignancy.

4. patients with cardiopulmonary diseases.

Related Conditions & MeSH terms

• Pancreas Neoplasm
• Pancreatic Neoplasms

Intervention

Procedure:
• laparoscopic assisted pancreaticoduodenectomy
laparoscopic assisted pancreaticoduodenectomy.
• Open pancreaticduodenctomy
Open pancreaticduodenctomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

Bausch D, Keck T. Minimally Invasive Surgery of Pancreatic Cancer: Feasibility and Rationale. Visc Med. 2018 Dec;34(6):440-443. doi: 10.1159/000495324. Epub 2018 Nov 28. Review. — View Citation

Correction to Lancet Gastroenterol Hepatol 2019; 4: 934-47. Lancet Gastroenterol Hepatol. 2020 Mar;5(3):e2. doi: 10.1016/S2468-1253(20)30018-2. — View Citation

Erratum to "Cancer statistics, 2021". CA Cancer J Clin. 2021 Jul;71(4):359. doi: 10.3322/caac.21669. Epub 2021 Apr 19. — View Citation

Newhook TE, LaPar DJ, Lindberg JM, Bauer TW, Adams RB, Zaydfudim VM. Morbidity and mortality of pancreaticoduodenectomy for benign and premalignant pancreatic neoplasms. J Gastrointest Surg. 2015 Jun;19(6):1072-7. doi: 10.1007/s11605-015-2799-y. Epub 2015 Mar 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post operative pain.	Compare the post operative pain betweenopen and laparoscopic assisted pancreaticoduodenectomy	Compare the post operative pain between open and laparoscopic assisted pancreaticoduodenctomy in the first week after operation
Primary	Blood loss	Compare between the intra operative blood loss in the open and laparoscopic assisted pancreaticoduodenectomy	Compare the intra operative blood loss between open and laparoscopic assisted pancreaticoduodenectomy during the operation
Primary	Rate of postoperative anastomosis leakage(pancreatic,billary and intestinal).	Compare the rate of postoperative anastomosis leakage(pancreatic,billary and intestinal) between the open and laparoscopic assisted pancreaticoduodenctomy	Rate of postoperative anastomosis leakage(pancreatic,billary and intestinal) in the first month after operation
Secondary	Postoperative haemorrhage	Compare between the postoperative haemorrhage by cc in the open and laparoscopic assisted pancreaticoduodenectomy	In the first 2 weeks
Secondary	Postoperative wound infection.	Compare between the postoperative wound infection in the open and laparoscopic assisted pancreaticoduodenectomy	In the first 2 weeks
Secondary	Starting oral feeding	Compare between starting oral feeding in the open and laparoscopic assisted pancreaticoduodenectomy	In the first 3 days after operation
Secondary	Postoperative 30 days mortality rate.	Compare between the Postoperative 30 days mortality rate in the open and laparoscopic assisted pancreaticoduodenectomy	In the first 30days after operation