Open Versus Laparoscopic Assisted Pancreaticoduodenectomy

Assiut University

Status: Not yet enrolling

Conditions: Pancreas Neoplasm

Treatments: Procedure: laparoscopic assisted pancreaticoduodenectomy; Procedure: Open pancreaticduodenctomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05463328

pancreaticoduodenectomy

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Laparoscopic assisted pancreaticoduodenctomy

Experimental group

Description:

If inclusion criteria are met ,these group of patients will undergo Laparoscopic assisted pancreaticoduodenctomy.

Treatment:

Procedure: laparoscopic assisted pancreaticoduodenectomy

Open pancreaticduodenctomy

Active Comparator group

Description:

criteria are met ,these group of patients will undergo open pancreaticoduodenctomy

Treatment:

Procedure: Open pancreaticduodenctomy